Download Leading the Way in PTA Bard PTA Family of Products

Leading the Way in PTA
Bard PTA Family of Products
Bard, Advancing Lives and the Delivery of Health Care, Atlas, Atlas Gold, Checker, Conquest, Dorado, GeoAlign, Lutonix, Presto, Ultra-Cross, Ultraverse, and VascuTrak are trademarks and/or
registered trademarks of C. R. Bard, Inc. or an affiliate. All other trademarks are property of their respective owners. Copyright © 2016, C. R. Bard, Inc. All Rights Reserved. Illustrations by Mike
Austin. Copyright © 2016. All Rights Reserved. Bard Peripheral Vascular, Inc. | 1 800 321 4254 | www.bardpv.com | 1625 W. 3rd Street Tempe, AZ 85281 BPV/BPAL/0916/0047(2)
Advancing Lives and the Delivery of Health Care™
A Brief History
of Anatomical Solutions
PTA Dilatation Catheter
As a leader in the peripheral vascular industry, Bard takes pride in fulfilling
the clinical needs of our customers and patients. From our first arterial
prosthesis developed in 1954, Bard has demonstrated commitment to
innovative medical technology by introducing surgical and interventional
devices for peripheral vascular patency, while providing exceptional
service and support to surgeons, interventionalists and radiologists.
PTA Solutions Table of Contents
Drug Coated Balloon Solutions for .035"
LUTONIX® 035 | 5F Drug Coated Balloon PTA Catheter .................................... 2
Standard Solutions for .035"
DORADO® PTA Dilatation Catheter .................................................................... 4
ULTRAVERSE® 035 PTA Dilatation Catheter ....................................................... 5
Large Diameter Vessel Solutions for .035"
ATLAS® PTA Dilatation Catheter ........................................................................ 6
ATLAS® Gold PTA Dilatation Catheter .............................................................. 7
Ultra Non-Compliant Solutions for .035"
CONQUEST® PTA Dilatation Catheter ................................................................ 8
CONQUEST® 40 PTA Dilatation Catheter ........................................................... 9
Small Vessel Solutions for .018"
ULTRAVERSE® 018 PTA Dilatation Catheter ...................................................... 10
Small Vessel Solutions for .014"
ULTRAVERSE® 014 PTA Dilatation Catheter ...................................................... 11
ULTRAVERSE® RX PTA Dilatation Catheter ....................................................... 12
Specialty Solutions for .014"
VASCUTRAK® PTA Dilatation Catheter............................................................... 13
Accessory Solutions
PRESTO® Inflation Device ................................................................................ 14
Ordering Information ................................................................................... 15
Quick Reference Guide .............................................................................. 21
Glossary of Terms ........................................................................................ 22
Product IFUs .................................................................................................. 23
1
D R U G
C O A T E D
B A L L O O N
S O L U T I O N S
F O R
. 0 3 5 "
D R U G
C O A T E D
B A L L O O N
S O L U T I O N S
F O R
. 0 3 5 "
Maximized
Effectiveness
Indisputable Safety
· First FDA-approved DCB in the U.S.
· All sizes 5F
· Zero preclinical evidence of downstream necrosis at 90 days*
· GEOALIGN® Marking System
· 89.2% Freedom from TLR at 24 months in LUTONIX® Global
SFA Real-World Registry**
Baseline
Pre-Dilatation
x3 Inflations
Post
Pre-Dilatation
Treatment
DCB
Post
Treatment
Recommended Guidewire .035"
2
Balloon Diameters
4 - 7 mm
Balloon Lengths
40 - 150 mm
Shaft Lengths
75, 130 cm
Rated Burst Pressure
12 atm
Nominal Pressure
6 atm (4, 5 mm), 7 atm (6, 7 mm)
Drug
Paclitaxel (2 μg/mm2)
Excipient
Polysorbate and Sorbitol
**
* Comparison of Particulate Embolization after Femoral Artery Treatment with In.Pact™ Admiral versus LUTONIX® 035 PaclitaxelCoated Balloons in Healthy Swine. Frank D. Kolodgie, PhD, Erica Pacheco, MS, Kazuyuki Yahagi, MD, Hiroyoshi Mori, MD, Elena
Ladich, MD, and Renu Virmani, MD, JVIR September 2016. Animal test results may not be indicative of clinical performance.
Different test methods may yield different results.
** Primary efficacy endpoint is defined as freedom from TLR at 12 months. Total of 639 subjects were evaluable for the primary
efficacy endpoint analysis. The 12 month TLR Free rate by subject counts at 12 months was 93.6%. The Kaplan-Meier estimates
TLR-Free survival was 94.2% at 12 month and 89.2% at 24 months. TLR-Free survival by lesion location was 94.8% (n=483)
for SFA, 94.0% (n=86) for popliteal, and 92.2% (n=121) for patients with lesion in both SFA and popliteal.
Please refer to the LUTONIX® 035 IFU for complete data sets and more detailed LUTONIX® 035 DCB clinical information, including
with regard to the LUTONIX® DCB Global SFA Registry and the LEVANT 2 global, prospective, randomized, pivotal study.
3
S T A N D A R D
S O L U T I O N S
F O R
. 0 3 5 "
S T A N D A R D
S O L U T I O N S
. 0 3 5 "
Ultra Non-Compliance
for Challenging Cases
Performance
Meets Precision
· Ultra non-compliant fiber balloon technology concentrates maximum
dilatation force at the lesion
· Sheath profile 5F compatible up to 8 x 80 mm*
·CHECKER® Flex Points provide increased flexibility in tortuous anatomy
· Indicated for post-stent dilatation
Pre DORADO® Catheter balloon dilatation
Pre AV Access
Post DORADO® Catheter balloon dilatation
Post AV Access
· Balloon Diameters: 3 - 12 mm
Balloon Lengths: 20 - 300 mm
· GEOALIGN® Marking System is designed to help
reduce radiation exposure**
Recommended Guidewire .035"
4
F O R
Recommended Guidewire .035"
Balloon Diameters
3 - 10 mm
Balloon Diameters
3 - 12 mm
Balloon Lengths
2 - 20 cm
Balloon Lengths
20 - 300 mm
Shaft Lengths
40, 80, 120, 135 cm
Shaft Lengths
75, 130 cm
Rated Burst Pressure
up to 24 atm
Rated Burst Pressure
up to 21 atm
Nominal Pressure
8 atm
Nominal Pressure
6 - 8 atm
Material
Composite
Material
Nylon
The GEOALIGN® Marking System is not a replacement for fluoroscopy. When the catheter is exposed to the
vascular system, the location of the balloon should be confirmed while under high quality fluoroscopic observation.
* 7 x 250 mm and 7 x 300 mm sizes are 6F compatible
** When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation
5
L A R G E
D I A M E T E R
V E S S E L
S O L U T I O N S
F O R
. 0 3 5 "
L A R G E
D I A M E T E R
V E S S E L
S O L U T I O N S
F O R
. 0 3 5 "
Ultra Non-Compliant
Technology
Enhanced
Trackability with
Tapered Tip
· Large diameter, ultra non-compliant balloon technology
· Delivers maximum dilatation force to resistant lesions
· Shorter shoulders designed to minimize
vessel straightening
· Large working range for maximum versatility
· 12 mm - 26 mm available diameters
· 12 mm - 26 mm available diameters
· All 12 - 26 mm diameters available in 80
cm and 120 cm shaft lengths
ATLAS® Gold
Recommended Guidewire .035"
12 - 26 mm
Balloon Lengths
2 - 6 cm
Shaft Lengths
75, 120 cm
Rated Burst Pressure
up to 18 atm
Nominal Pressure
4 - 6 atm
Material
Composite
Recommended Guidewire .035"
Highest Rated Burst Pressure*
20
Atmospheres (ATM)
Balloon Diameters
XXL™
21 mm
18 ATM
21 mm
ATLAS® Gold 18 mm x 4 cm Balloon
15
Balloon Diameters
12 - 26 mm
Balloon Lengths
2 - 6 cm
Shaft Lengths
80, 120 cm
Rated Burst Pressure
up to 18 atm
Nominal Pressure
4 - 6 atm
Material
Composite
10 ATM
10
8 ATM
38 mm
6 ATM
38 mm
5
9F
7F
XXL™ 18 mm x 4 cm Balloon
7F
9F
XXL
Maxi LD
0
ATLAS
®
Impact
™
™
™
Short shoulders designed to minimize vessel straightening.*
Images shown are not to scale.
PTA Dilatation Catheter
6
* Information taken directly from each manufacturer’s product brochure and IFU. Highest rated burst pressure among competitors listed.
* Simulated model. Bench test data on file. Bench results may not be indicative of clinical performance. Different test methods may yield different results.
7
U L T R A
N O N - C O M P L I A N T
S O L U T I O N S
F O R
. 0 3 5 "
U L T R A
N O N - C O M P L I A N T
S O L U T I O N S
F O R
. 0 3 5 "
The Force You Need to
Conquer Resistant Lesions
Strength that
Reaches High
Atmospheres
· Allows high pressures without overexpansion
· Enables a single balloon strategy with up to 40 atm
· Predictable balloon diameters
· Tapered tip for advanced delivery
· Virtually no balloon growth, even at high pressures
· Fast inflation and deflation
· Delivers maximum forces to areas of most resistance
· Literature suggests that 99% of stenoses in hemodialysis access can be treated in the range up to
40 atm*
· Puncture resistant, composite balloon materials
1.) 3 cm long high-grade stenosis involving the upper basilic vein
2.) Unable to efface stenosis with standard, non-compliant balloon at 22 atm
Recommended Guidewire .035"
8
Recommended Guidewire .035"
Balloon Diameters
5 - 12 mm
Balloon Diameters
4 - 12 mm
Balloon Lengths
2 - 8 cm
Balloon Lengths
2 - 10 cm
Shaft Lengths
50, 75, 120 cm
Shaft Lengths
50, 75 cm
Rated Burst Pressure
up to 30 atm
Rated Burst Pressure
up to 40 atm
Nominal Pressure
8 atm
Nominal Pressure
8 atm
Material
Composite
Material
Composite
3.) Ultra high pressure and ultra non-compliance were needed to efface lesion.
4.) Post angioplasty, the vessel is open and the patient can resume dialysis
Images courtesy of Thomas Vesely, MD. Results from this case may not be predictive for all patients. Individual results may vary depending on a varitety of patient specific attributes.
* Foering K, Chittams JL, Trerotola SO, Percutaneous Transluminal Angioplasty Balloon Inflation with Syringes: Who Needs an Inflator? J Vasc Interv Radiol. 2009; 20:629-633
Terotola SO, et al. Prospective Study of Balloon Inflation Pressures and Other Technical Aspects of Hemodialysis Access Angioplasty J Vasc Interv Radiol. 2005; 16:1613-1618
9
S M A L L
V E S S E L
S O L U T I O N S
F O R
. 0 1 4 "
S M A L L
V E S S E L
S O L U T I O N S
F O R
. 0 1 4 "
Going the
Distance
Navigating the
Extremes
· Exceptional Trackability
· Designed to deliver below the knee
· 200 cm shaft - longest on the market for
.014" RX PTA balloons
· Excellent trackability
· Superior pushability vs. competitive over-thewire balloons
· Balloon lengths up to 300 mm
· Longest balloon lengths on the U.S. market up to 300 mm
Highly Lubricious
Top Layer
ULTRA-CROSS™ Dual Layer
Hydrophilic coating
Highly Lubricious
Top Layer
Highly Durable
Bottom Layer
ULTRA-CROSS™ Dual Layer
Hydrophilic coating
Reinforced Inner
Lumen
Highly Durable
Bottom Layer
CHECKER™ Flex Points
Reinforced Inner
Lumen
CHECKER™ Flex Points
· ULTRA-CROSS™ Dual Layer Hydrophilic coating
designed to reduce friction
· ULTRA-CROSS™ Dual Layer Hydrophilic coating
designed to reduce friction
· CHECKER™ Flex Points engineered to allow the
balloon to flex in tortuous anatomy
· CHECKER™ Flex Points engineered to allow the
balloon to flex in tortuous anatomy
· Reinforced inner lumen provides improved axial
strength constructed to cross tight lesions
· Reinforced inner lumen provides improved axial
strength constructed to cross tight lesions
Recommended Guidewire .014"
Balloon Diameters
1.25 - 7.0 mm
Balloon Diameters
1.5 - 5.0 mm
Balloon Lengths
15 - 300 mm
Balloon Lengths
2 - 30 cm
Shaft Lengths
150, 200 cm*
Shaft Lengths
150 cm
Rated Burst Pressure
up to 16 atm
Rated Burst Pressure
up to 16 atm
Nominal Pressure
6 atm
Nominal Pressure
6 atm
Material
Nylon
Material
10
Recommended Guidewire .014"
* As of January 2016
Nylon
ULTRAVERSE 014 Catheter
navigating a tortuous anatomy
®
11
S M A L L
V E S S E L
S O L U T I O N S
F O R
. 0 1 8 "
S P E C I A L T Y
S O L U T I O N S
F O R
. 0 1 8 " / . 0 1 4 "
Navigating the
Extremes
Concentrated
Force at Low
Pressures
· Optimal deliverability
· Two external wires deliver focused force along
the length of the balloon
· Broad size matrix with balloon lengths up to 300 mm
· Flexible wires are designed to efface lesions
· Fractures the plaque in a longitudinal direction
thus potentially reducing flow-limiting
dissections
· Balloon lengths up to 300 mm
Popliteal CTO
pre-intervention
Post crossing and
ULTRAVERSE® 018 Catheter
· ULTRA-CROSS™ Dual Layer Hydrophilic coating
designed to reduce friction
· CHECKER™ Flex Points engineered to allow the
balloon to flex in tortuous anatomy
· Reinforced inner lumen provides improved axial
strength constructed to cross tight lesions
Recommended Guidewire .018"
12
Recommended Guidewire .018"/.014”
Balloon Diameters
2 - 9 mm
Balloon Diameters
2 - 7 mm
Balloon Lengths
2 - 30 cm
Balloon Lengths
2 - 30 cm
Shaft Lengths
75, 130, 150 cm
Shaft Lengths
80, 140 cm
Rated Burst Pressure
up to 16 atm
Rated Burst Pressure
12 atm
Nominal Pressure
6 atm
Nominal Pressure
6, 8 atm
Material
Nylon
Material
Nylon
13
A C C E S S O R Y
Inflating to
Ultra-High
Atmospheres
S O L U T I O N S
O R D E R I N G
ATLAS® .035" PTA Dilatation Catheter
Large Diameter 75 cm & 120 cm Catheter Lengths
Diameter
(mm)
Length
(cm)
2
18
12
4
18
6
18
7
AT75126
14
16
· Ergonomic design allows for comfortable handling
· No inflation device on the U.S. market has higher
inflation pressures* - up to 40 atm
· Large barrel allows for rapid and easy deflation
I N F O R M A T I O N
18
20
22
24
26
RBP
(ATM)
Sheath
(F)
ATLAS® GOLD™ .035" PTA Dilatation Catheter
Large Diameter 80 cm & 120 cm Catheter Lengths
75 cm
Product Codes
120 cm
Product Codes
7
AT75122
AT120122
7
AT75124
AT120124
Diameter
(mm)
Length
(cm)
2
18
12
4
18
6
18
-
2
18
7
AT75142
AT120142
4
18
7
AT75144
AT120144
6
18
8
AT75146
2
18
8
AT75162
AT120162
4
18
8
AT75164
AT120164
6
16
8
AT75166
2
16
8
AT75182
AT120182
4
16
8
AT75184
AT120184
6
16
9
AT75186
2
16
9
AT75202
AT120202
4
16
9
AT75204
AT120204
2
14
10
AT75222
-
4
14
10
AT75224
-
2
14
10
AT75242
-
4
14
10
AT75244
-
2
12
12
AT75262
-
4
12
12
AT75264
-
14
-
16
-
18
20
22
24
26
CONQUEST® .035" PTA Dilatation Catheter
High Pressure 50 cm, 75 cm & 120 cm Catheter Lengths
Diameter
(mm)
5
6
7
8
9
10
12
14
* As of November 2016 for 30 cc inflation devices
Length
(cm)
RBP
(ATM)
Sheath
(F)
50 cm
75 cm
120 cm
Product Codes Product Codes Product Codes
2
30
6
CQ5052
CQ7552
RBP*
(ATM)
Sheath
(F)
80 cm
Product Codes
120 cm
Product Codes
7
ATG80122
ATG120122
7
ATG80124
ATG120124
7
ATG80126
ATG120126
2
18
7
ATG80142
ATG120142
4
18
7
ATG80144
ATG120144
6
18
8
ATG80146
ATG120146
2
18
8
ATG80162
ATG120162
4
18
8
ATG80164
ATG120164
6
16
8
ATG80166
ATG120166
2
16
8
ATG80182
ATG120182
4
16
8
ATG80184
ATG120184
6
16
9
ATG80186
ATG120186
2
16
9
ATG80202
ATG120202
4
16
9
ATG80204
ATG120204
2
14
10
ATG80222
ATG120222
4
14
10
ATG80224
ATG120224
2
14
10
ATG80242
ATG120242
4
14
10
ATG80244
ATG120244
2
12
12
ATG80262
ATG120262
4
12
12
ATG80264
ATG120264
CONQUEST® 40 .035" PTA Dilatation Catheter
High Pressure 50 cm & 75 cm Catheter Lengths
Diameter
(mm)
CQ12054
Length
(cm)
RBP*
(ATM)
Sheath
(F)
50 cm
Product Codes
75 cm
Product Codes
2
40
6
CQF5042
CQF7542
4
6
40
6
CQF5044
CQF7544
40
6
CQF5046
CQF7546
4
30
6
CQ5054
CQ7554
8
27
6
CQ5058
CQ7558
2
30
6
CQ5062
CQ7562
CQ12062
8
40
6
CQF5048
CQF7548
4
30
6
CQ5064
CQ7564
CQ12064
10
40
6
CQF50410
CQF75410
8
27
6
CQ5068
CQ7568
2
40
6
CQF5052
CQF7552
2
30
6
CQ5072
CQ7572
CQ12072
4
40
6
CQF5054
CQF7554
4
30
6
CQ5074
CQ7574
CQ12074
6
27
6
CQ5076
CQ7576
8
27
6
CQ5078
CQ7578
2
27
6
CQ5082
CQ7582
3
27
6
CQ5083
CQ7583
-
4
-
6
40
6
CQF5056
CQF7556
-
8
40
6
CQF5058
CQF7558
-
10
40
6
CQF50510
CQF75510
2
40
6
CQF5062
CQF7562
4
40
6
CQF5064
CQF7564
5
CQ12082
-
4
27
6
CQ5084
CQ7584
6
40
6
CQF5066
CQF7566
6
25
6
CQ5086
CQ7586
CQ12084
-
8
40
6
CQF5068
CQF7568
8
25
6
CQ5088
CQ7588
-
10
40
6
CQF50610
CQF75610
2
26
7
CQ5092
CQ7592
4
26
7
CQ5094
CQ7594
2
24
7
-
CQ75102
4
24
7
-
CQ75104
2
20
8
-
CQ75122
-
4
20
8
-
CQ75124
-
6
CQ12094
CQ120104
7
2
40
6
CQF5072
CQF7572
4
40
6
CQF5074
CQF7574
6
40
6
CQF5076
CQF7576
8
40
6
CQF5078
CQF7578
10
40
6
CQF50710
CQF75710
CONTINUED >
15
O R D E R I N G
I N F O R M A T I O N
CONQUEST® 40 .035" PTA Dilatation Catheter
High Pressure 50 cm & 75 cm Catheter Lengths
Diameter
(mm)
8
9
10
12
Length
(cm)
RBP*
(ATM)
Sheath
(F)
DORADO® .035" PTA Dilatation Catheter
Standard 40 cm & 80 cm Catheter Lengths
50 cm
Product Codes
75 cm
Product Codes
Length
(cm)
15
22
6
-
DR80715
7
17
22
6
-
DR80717
20
22
6
-
DR80720
4
40
6
CQF5082
CQF7582
6
CQF5083
CQF7583
4
40
6
CQF5084
CQF7584
6
35
6
CQF5086
CQF7586
2
22
6
DR4082
8
35
6
CQF5088
CQF7588
4
22
6
DR4084
10
35
6
CQF50810
CQF75810
6
22
6
-
DR8086
2
35
7
CQF5092
CQF7592
8
22
6
-
DR8088
4
35
7
CQF5094
CQF7594
10
20
6
-
8
35
7
CQF5098
CQF7598
2
35
7
-
CQF75102
4
35
7
-
CQF75104
8
35
7
-
CQF75108
2
30
8
-
CQF75122
4
30
8
-
CQF75124
8
9
10
Sheath
(F)
40 cm
Product Codes
2
24
5
-
DR8032
80 cm
Product Codes
40
12
5
LX35754405F
LX351304405F
60
12
5
LX35754605F
LX351304605F
2
22
6
-
DR13572
80
12
5
LX35754805F
LX351304805F
DR8082
4
22
6
DR12074
DR13574
100
12
5
LX357541005F
LX3513041005F
DR8084
10
22
6
DR120710
DR135710
120
12
5
-
LX3513041205F
12
22
6
-
DR135712
150
12
5
-
LX3513041505F
15
22
6
-
DR135715
40
12
5
LX35755405F
LX351305405F
DR80810
17
22
6
-
DR135717
60
12
5
LX35755605F
LX351305605F
6
-
DR8092
20
22
6
-
DR135720
6
DR4094
DR8094
2
22
6
-
DR13582
8
20
6
-
DR8098
4
22
6
10
20
6
4
20
6
2
20
6
-
DR80102
4
20
6
-
DR80104
8
20
7
-
DR80108
Length
(cm)
RBP
(ATM)
Sheath
(F)
120 cm
Product Codes
135 cm
Product Codes
2
24
5
-
DR13532
DR8034
4
24
5
-
DR13534
DR80310
10
24
5
-
DR135310
2
24
5
DR4042
DR8042
2
24
5
-
DR13542
4
24
5
DR4044
DR8044
4
24
5
DR12044
DR13544
10
24
5
-
DR80410
10
24
5
DR120410
DR135410
2
24
5
DR4052
12
24
6
6
-
DR135412
24
5
-
DR8056
17
24
6
-
DR135417
8
24
5
-
DR8058
20
24
6
-
DR135420
-
DR80510
2
24
5
2
24
6
DR4062
DR8062
4
24
5
4
24
6
DR4064
DR8064
6
24
5
6
24
6
-
DR8066
8
24
6
-
DR8068
10
22
6
-
5
DR80610
8
24
5
10
24
5
12
24
6
DR12052
DR12054
DR120510
-
DR13554
15
24
6
-
DR135515
15
22
6
-
DR80615
17
24
6
-
DR135517
6
-
2
22
6
DR4072
20
DR80617
24
6
-
DR135520
DR80620
2
24
6
DR12062
DR13562
DR8072
4
24
6
DR12064
DR13564
4
22
6
DR4074
DR8074
6
22
6
-
DR8076
6
6
24
6
-
DR13566
8
24
6
-
DR13568
DR120610
12
5
LX35755805F
LX351305805F
12
5
LX357551005F
LX3513051005F
DR13584
120
12
5
-
LX3513051205F
-
DR135810
150
12
5
-
LX3513051505F
-
DR13594
40
12
5
LX35756405F
LX351306405F
-
DR135102
60
12
5
LX35756605F
LX351306605F
DR135104
80
12
5
LX35756805F
LX351306805F
100
12
5
LX357581005F
LX3513061005F
120
12
5
-
LX3513061205F
150
12
5
-
LX3513061505F
40
12
5
LX35757405F
LX351307405F
60
12
5
LX35757605F
LX351307605F
DR120104
5/Box
5
6
8
22
6
-
DR8078
10
22
6
10
22
6
-
DR80710
12
22
6
-
DR135612
12
22
6
-
DR80712
15
22
6
-
DR135615
Product Code
7
ID4030
ULTRAVERSE® .014" PTA Dilatation Catheter
150 cm Catheter Lengths
ULTRAVERSE® .014" PTA Dilatation Catheter
150 cm Catheter Lengths
ULTRAVERSE® .014" PTA Dilatation Catheter
150 cm Catheter Lengths
Diameter
(mm)
Diameter
(mm)
1.5
2
DR135512
DR80612
22
6
6
PRESTO™ Inflation Device
DR135510
-
20
20
20
Quatntity
DR13558
6
-
2
4
80
100
DR12084
Description
DR13556
22
6
10
DR13552
12
22
9
DR135415
6
5
8
4
PRESTO™ Inflation Device
-
24
7
20
24
130 cm
Product Codes
DR135620
20
15
75 cm
Product Codes
DR135617
-
DR8054
Sheath
(F)
-
5
DR4054
RBP*
(ATM)
-
2
-
Length
(mm)
6
4
*
Diameter
(mm)
6
5
4
135 cm
Product Codes
22
24
DR8052
3
120 cm
Product Codes
22
24
CONTINUED >
16
Diameter
(mm)
Sheath
(F)
17
4
5
RBP*
(ATM)
LUTONIX® .035" Drug Coated Balloon PTA Catheter | 5F
75 cm & 130 cm Catheter Lengths
20
10
24
Length
(cm)
6
DORADO .035" PTA Dilatation Catheter
Standard 120 cm & 135 cm Catheter Lengths
RBP
(ATM)
*
Diameter
(mm)
®
Length
(cm)
17
7
80 cm
Product Codes
40
10
6
40 cm
Product Codes
2
4
5
Sheath
(F)
3
DORADO .035" PTA Dilatation Catheter
Standard 40 cm & 80 cm Catheter Lengths
3
RBP*
(ATM)
I N F O R M A T I O N
DORADO® .035" PTA Dilatation Catheter
Standard 120 cm & 135 cm Catheter Lengths
Diameter
(mm)
®
Diameter
(mm)
O R D E R I N G
2.5
Length
(cm)
RBP*
(ATM)
Sheath
(F)
150 cm
Product Codes
2
16
4
U41501H2
2.5
Length
(cm)
RBP*
(ATM)
Sheath
(F)
150 cm
Product Codes
Diameter
(mm)
Length
(cm)
RBP*
(ATM)
Sheath
(F)
150 cm
Product Codes
22
15
4
U41502H22
3.5
30
15
4
U41503H30
4
16
4
U41501H4
30
15
4
U41502H30
2
16
4
U415042
12
16
4
U41501H12
2
16
4
U415032
4
16
4
U415044
2
16
4
U415022
4
16
4
U415034
8
15
4
U415048
4
16
4
U415024
8
15
4
U415038
10
15
4
U4150410
8
15
4
U415028
10
15
4
U4150310
12
15
4
U4150412
10
15
4
U4150210
12
15
4
U4150312
15
15
5
U4150415
12
15
4
U4150212
15
15
4
U4150315
22
15
5
U4150422
15
15
4
U4150215
22
15
4
U4150322
30
15
5
U4150430
22
15
4
U4150222
30
15
4
U4150330
2
14
5
U415052
30
15
4
U4150230
2
16
4
U41503H2
4
14
5
U415054
2
16
4
U41502H2
4
16
4
U41503H4
8
13
5
U415058
4
16
4
U41502H4
10
13
5
U4150510
8
15
4
U41502H8
12
13
5
U4150512
10
15
4
12
15
15
15
3
4
8
15
4
U41503H8
10
15
4
U41503H10
U41502H10
12
15
4
U41503H12
15
13
5
U4150515
4
U41502H12
15
15
4
U41503H15
22
13
5
U4150522
4
U41502H15
22
15
4
U41503H22
30
13
5
U4150530
CONTINUED >
3.5
5
CONTINUED >
DR135610
CONTINUED >
17
O R D E R I N G
I N F O R M A T I O N
ULTRAVERSE® .018" PTA Dilatation Catheter
75 cm, 130 cm & 150 cm Catheter Lengths
Diameter
(mm)
2
2.5
3
3.5
Length
(cm)
RBP
(ATM)
Sheath
(F)
75 cm
130 cm
Product Codes Product Codes
O R D E R I N G
ULTRAVERSE® .018" PTA Dilatation Catheter
75 cm, 130 cm & 150 cm Catheter Lengths
150 cm
Product Codes
RBP
(ATM)
Sheath
(F)
75 cm
130 cm
Product Codes Product Codes
ULTRAVERSE® .035" PTA Dilatation Catheter
75 cm & 130 cm Catheter Lengths
Diameter
(mm)
Length
(cm)
15
15
4
U81303H15
U81503H15
150
19
3.5
22
15
4
-
U81303H22
U81503H22
200
19
U81303H30
U81503H30
250
19
2
16
4
U87522
U813022
U815022
4
16
4
U87524
U813024
U815024
U8753H15
6
16
4
-
U813026
U815026
30
15
4
-
-
150 cm
Product Codes
RBP
(ATM)
Sheath
(F)
75 cm
Product Codes
130 cm
Product Codes
Diameter
(mm)
5
U3575415
U35130415
100
11
5
U3575420
U35130420
120
11
5
U3575425
U35130425
150
11
7
Length
(mm)
RBP
(ATM)
Sheath
(F)
75 cm
Product Codes
130 cm
Product Codes
5
U3575710
U35130710
5
U3575712
U35130712
5
U3575715
U35130715
15
4
U813028
U815028
2
16
4
U87542
U813042
U815042
300
19
5
U3575430
U35130430
200
11
5
U3575720
U35130720
15
4
U875210
U8130210
U8150210
4
16
4
U87544
U813044
U815044
20
17
5
U357552
U3513052
250
11
6
U3575725
U35130725
12
15
4
U875212
U8130212
U8150212
6
16
4
U87546
U813046
U815046
40
17
5
U357554
U3513054
300
11
6
U3575730
U35130730
15
15
4
U875215
U8130215
U8150215
8
15
4
-
U813048
U815048
60
17
5
U357556
U3513056
20
10
5
U357582
U3513082
22
15
4
U875222
U8130222
U8150222
10
15
4
U875410
U8130410
U8150410
80
17
5
U357558
U3513058
40
10
5
U357584
U3513084
30
15
4
U8130230
U8150230
12
15
4
U875412
U8130412
U8150412
100
16
5
U3575510
U35130510
60
10
5
U357586
U3513086
2
16
4
U8752H2
U81302H2
U81502H2
15
15
5
U875415
U8130415
U8150415
120
16
5
U3575512
U35130512
80
10
5
U357588
U3513088
4
16
4
U8752H4
U81302H4
U81502H4
22
15
5
U875422
U8130422
U8150422
150
16
5
U3575515
U35130515
100
13
6
U3575810
U35130810
6
16
4
-
U81302H6
U81502H6
30
15
5
-
U8130430
U8150430
200
16
5
U3575520
U35130520
120
13
6
U3575812
U35130812
8
15
4
-
U81302H8
U81502H8
2
14
5
U87552
U813052
U815052
250
16
5
U3575525
U35130525
150
13
6
U3575815
U35130815
10
15
4
U81302H10
U81502H10
4
14
5
U87554
U813054
U815054
300
16
5
U3575530
U35130530
200
13
6
U3575820
U35130820
12
15
4
U81302H12
U81502H12
6
14
5
U87556
U813056
U815056
20
15
5
U357562
U3513062
20
12
6
U357592
U3513092
15
15
4
U81302H15
U81502H15
8
13
5
-
U813058
U815058
40
15
5
U357564
U3513064
40
12
6
U357594
U3513094
22
15
4
-
U81302H22
U81502H22
10
13
5
U875510
U8130510
U8150510
60
15
5
U357566
U3513066
60
11
6
U357596
U3513096
30
15
4
-
U81302H30
U81502H30
12
13
5
U875512
U8130512
U8150512
80
15
5
U357568
U3513068
80
11
6
U357598
U3513098
2
16
4
U87532
U813032
U815032
15
13
5
U875515
U8130515
U8150515
100
14
5
U3575610
U35130610
100
11
6
U3575910
U35130910
4
16
4
U87534
U813034
U815034
22
13
5
U875522
U8130522
U8150522
120
14
5
U3575612
U35130612
20
11
6
U3575102
U35130102
6
16
4
-
U813036
U815036
30
13
5
-
U8130530
U8150530
150
14
5
U3575615
U35130615
40
11
6
U3575104
U35130104
-
-
U8752H10
U8752H15
4
5
5
6
8
9
8
15
4
U813038
U815038
2
14
5
U87562
U813062
-
200
14
5
U3575620
U35130620
60
10
6
U3575106
U35130106
10
15
4
U875310
U8130310
U8150310
4
14
5
U87564
U813064
-
250
14
5
U3575625
U35130625
80
10
6
U3575108
U35130108
12
15
4
U875312
U8130312
U8150312
6
14
5
U87566
U813066
-
300
14
5
U3575630
U35130630
100
10
6
U35751010
U351301010
15
15
4
U875312
U8130315
U8150315
-
22
15
4
U875322
U8130322
U8150322
30
15
4
U8130330
2
16
4
U8753H2
4
16
4
U8753H4
6
16
4
8
15
4
10
15
4
12
15
4
8
12
5
U813068
-
20
14
5
U357572
U3513072
20
11
7
U3575122
U35130122
12
5
U875610
U8130610
-
40
14
5
U357574
U3513074
40
11
7
U3575124
U35130124
U8150330
12
12
5
U875612
U8130612
-
60
14
5
U357576
U3513076
60
9
7
U3575126
U35130126
U81303H2
U81503H2
15
12
5
U875615
U8130615
-
80
14
5
U357578
U3513078
80
9
7
U3575128
U35130128
U81303H4
U81503H4
22
12
5
U875622
U8130622
-
100
9
7
U35751210
U351301210
-
U81303H6
U81503H6
30
12
5
-
U8130630
-
-
U81303H8
U81503H8
7
4
12
5
U87574
U813074
-
U81303H10
U81503H10
8
4
12
6
U87584
U813084
-
U81303H12
U81503H12
9
4
11
6
U87594
U813094
-
-
U8753H10
-
Length
(mm)
RBP
(ATM)
Sheath
(F)
20
21
40
60
10
10
6
75 cm
Product Codes
130 cm
Product Codes
5
U357532
U3513032
21
5
U357534
U3513034
21
5
U357536
U3513036
80
21
5
U357538
U3513038
100
19
5
U3575310
U35130310
120
19
5
U3575312
U35130312
150
19
5
U3575315
200
19
5
U3575320
Diameter
(mm)
Sheath
(F)
250
19
300
20
CONTINUED >
ULTRAVERSE® RX PTA Dilatation Catheter
150 cm & 200 cm Catheter Lengths
Diameter
(mm)
ULTRAVERSE® RX PTA Dilatation Catheter
150 cm & 200 cm Catheter Lengths
Length
(mm)
RBP
(ATM)
Sheath
(F)
150 cm
Product Codes
200 cm
Product Codes
15
16
4
U41501Q1HRX
20
16
4
40
16
4
15
16
20
40
Diameter
(mm)
Length
(mm)
RBP
(ATM)
Sheath
(F)
150 cm
Product Codes
200 cm
Product Codes
U42001Q1HRX
100
15
4
U4150210RX
U4200210RX
U41501Q2RX
U42001Q2RX
120
15
4
U4150212RX
U4200212RX
U41501Q4RX
U42001Q4RX
150
15
4
U4150215RX
U4200215RX
4
U41501H1HRX
U42001H1HRX
200
15
4
U4150220RX
U4200220RX
16
4
U41501H2RX
U42001H2RX
250
15
4
U4150225RX
U4200225RX
16
4
U41501H4RX
U42001H4RX
300
15
4
U4150230RX
U4200230RX
2
130 cm
Product Codes
5
U3575325
U35130325
19
5
U3575330
U35130330
80
16
4
U41501H8RX
U42001H8RX
15
16
4
U41502H1HRX
U42002H1HRX
20
5
U357542
U3513042
120
16
4
U41501H12RX
U42001H12RX
20
16
4
U41502H2RX
U42002H2RX
40
20
5
U357544
U3513044
15
16
4
U415021HRX
U420021HRX
40
16
4
U41502H4RX
U42002H4RX
60
20
5
U357546
U3513046
20
16
4
U415022RX
U420022RX
60
16
4
U41502H6RX
U42002H6RX
80
20
5
U357548
U3513048
40
16
4
U415024RX
U420024RX
80
15
4
U41502H8RX
U42002H8RX
U35130315
100
19
5
U3575410
U35130410
60
16
4
U415026RX
U420026RX
100
15
4
U41502H10RX
U12002H10RX
U35130320
120
19
5
U3575412
U35130412
80
15
4
U415028RX
U420028RX
120
15
4
U41502H12RX
U42002H12RX
4
RBP
(ATM)
12
75 cm
Product Codes
3
Length
(mm)
7
1.25
ULTRAVERSE® .035" PTA Dilatation Catheter
75 cm & 130 cm Catheter Lengths
CONTINUED >
18
4
Length
(mm)
8
ULTRAVERSE® .035" PTA Dilatation Catheter
75 cm & 130 cm Catheter Lengths
3
Diameter
(mm)
ULTRAVERSE® .035" PTA Dilatation Catheter
75 cm & 130 cm Catheter Lengths
10
CONTINUED >
Diameter
(mm)
I N F O R M A T I O N
CONTINUED >
1.5
2
CONTINUED >
2.5
CONTINUED >
19
O R D E R I N G
I N F O R M A T I O N
ULTRAVERSE® RX PTA Dilatation Catheter
150 cm & 200 cm Catheter Lengths
Diameter
(mm)
Length
(mm)
2.5
3
3.5
RBP
(ATM)
O R D E R I N G
ULTRAVERSE® RX PTA Dilatation Catheter
150 cm & 200 cm Catheter Lengths
Sheath
(F)
150 cm
Product Codes
200 cm
Product Codes
Diameter
(mm)
Length
(mm)
RBP
(ATM)
I N F O R M A T I O N
VASCUTRAK® .018" PTA Dilatation Catheter
80 cm & 140 cm Catheter Lengths
Sheath
(F)
150 cm
Product Codes
200 cm
Product Codes
Diameter
(mm)
Length
(cm)
RBP
(ATM)
Sheath
(F)
VASCUTRAK® .018" PTA Dilatation Catheter
80 cm & 140 cm Catheter Lengths
80 cm
Product Codes
140 cm
Product Codes
Diameter
(mm)
Length
(cm)
RBP
(ATM)
Sheath
(F)
80 cm
Product Codes
140 cm
Product Codes
150
15
4
U41502H15RX
U42002H15RX
15
16
4
U415041HRX
U420041HRX
2
12
5
V184020S
V184020
2
12
7
V186020S
V186020
200
15
4
U41502H20RX
U42002H20RX
20
16
4
U415042RX
U420042RX
4
12
5
V184040S
V184040
4
12
7
V186040S
V186040
250
15
4
U41502H25RX
U42002H25RX
40
16
4
U415044RX
U420044RX
6
12
5
V184060S
V184060
6
12
7
V186060S
V186060
300
15
4
U41502H30RX
U42002H30RX
60
16
4
U415046RX
U420046RX
8
12
5
V184080S
V184080
8
12
7
V186080S
V186080
15
16
4
U415031HRX
U420031HRX
80
15
4
U415048RX
U420048RX
10
12
5
V1840100S
V1840100
10
12
7
V1860100S
V1860100
20
16
4
U415032RX
U420032RX
100
15
4
U4150410RX
U4200410RX
12
12
5
12
12
7
40
16
4
U415034RX
U420034RX
120
15
4
U4150412RX
U4200412RX
15
12
5
V1840150S
V1840150
15
12
7
V1860150S
V1860150
60
16
4
U415036RX
U420036RX
150
15
5
U4150415RX
U4200415RX
20
12
5
V1840200S
V1840200
20
12
7
V1860200S
V1860200
4
4
6
V1840120
-
V1860120
-
80
15
4
U415038RX
U420038RX
200
15
5
U4150420RX
U4200420RX
25
12
5
V1840250
25
12
7
100
15
4
U4150310RX
U4200310RX
250
15
5
U4150425RX
U4200425RX
30
12
5
V1840300S
V1840300
30
12
7
V1860300S
V1860300
120
15
4
U4150312RX
U4200312RX
300
15
5
U4150430RX
U4200430RX
2
12
6
V185020S
V185020
2
12
7
V187020S
V187020
150
15
4
U4150315RX
U4200315RX
15
14
5
U415051HRX
U420051HRX
4
12
6
V185040S
V185040
4
12
7
V187040S
V187040
200
15
4
U4150320RX
U4200320RX
20
14
5
U415052RX
U420052RX
6
12
6
V185060S
V185060
6
12
7
V187060S
V187060
250
15
4
U4150325RX
U4200325RX
40
14
5
U415054RX
U420054RX
8
12
6
V185080S
V185080
8
12
7
V187080S
V187080
300
15
4
U4150330RX
U4200330RX
60
14
5
U415056RX
U420056RX
10
12
6
V1850100S
V1850100
10
12
7
V1870100S
V1870100
15
16
4
U41503H1HRX
U42003H1HRX
80
13
5
U415058RX
U420058RX
12
12
6
12
12
7
-
V1870120
20
16
4
U41503H2RX
U42003H2RX
100
13
5
U4150510RX
U4200510RX
15
12
6
V1850150S
V1850150
15
12
7
-
V1870150
40
16
4
U41503H4RX
U42003H4RX
120
13
5
U4150512RX
U4200512RX
20
12
6
V1850200S
V1850200
20
12
7
-
V1870200
60
16
4
U41503H6RX
U42003H6RX
150
13
5
U4150515RX
U4200515RX
25
12
6
V1850250
25
12
7
-
V1870250
30
12
6
V1850300
30
12
7
-
V1870300
5
80
15
4
U41503H8RX
U42003H8RX
200
13
5
U4150520RX
U4200520RX
100
15
4
U41503H10RX
U42003H10RX
250
13
5
U4150525RX
U4200525RX
120
15
4
U41503H12RX
U42003H12RX
300
13
5
U4150530RX
U4200530RX
150
15
4
U41503H15RX
U42003H15RX
40
14
5
U415064RX
-
200
15
4
U41503H20RX
U42003H20RX
60
14
5
U415066RX
-
250
15
4
U41503H25RX
U42003H25RX
300
15
4
U41503H30RX
U42003H30RX
6
7
40
12
5
U415074RX
-
60
12
5
U415076RX
-
5
-
7
V1850120
-
V1850300S
V1860250
-
CONTINUED >
CONTINUED >
P T A
VASCUTRAK® .014" PTA Dilatation Catheter
140 cm Catheter Lengths
VASCUTRAK® .014" PTA Dilatation Catheter
140 cm Catheter Lengths
VASCUTRAK® .014" PTA Dilatation Catheter
140 cm Catheter Lengths
Diameter
(mm)
Diameter
(mm)
Diameter
(mm)
2
2.5
Q U I C K
R E F E R E N C E
G U I D E
Diameter (mm)
Length (cm)
RBP (ATM)
Sheath (F)
Shaft (cm)
Material
Category
Length
(cm)
RBP*
(ATM)
Sheath
(F)
150 cm
Product Codes
ATLAS® Catheter
12-26
2-6
up to 18
7-12
75, 120
Composite
.035" Large Diameter
ATLAS® Gold Catheter
12-26
2-6
up to 18
7-12
80, 120
Composite
.035" Large Diameter
V142580
15
12
5
V1430150
CONQUEST® Catheter
5-12
2-8
up to 30
6-8
50, 75, 120
Composite
.035" High Pressure
5
V1425100
20
12
5
V1430200
CONQUEST 40 Catheter
4-12
2-10
up to 40
6-8
50, 75
Composite
.035" High Pressure
5
V1425120
25
12
5
V1430250
DORADO® Catheter
2-9
2-30
up to 16
5-6
75, 130, 150
Nylon
12
5
V1425150
30
12
5
V1430300
LUTONIX® 035 | 5F Catheter
4-7
4-15
up to 12
5
75, 135
Drug Coated
.035" Drug Coated
20
12
5
V1425200
2
12
5
V143520
ULTRAVERSE® 014 Catheter
1.5-5
2-30
6
4-5
150
Nylon
.014" Small Vessel
V1420120
25
12
5
V1425250
4
12
5
V143540
ULTRAVERSE® 018 Catheter
2-9
2-30
6
4-6
75, 130, 150
Nylon
.018" Small Vessel
5
V1420150
30
12
5
V1425300
6
12
5
V143560
ULTRAVERSE 035 Catheter
3-12
2-30
6-8
5-7
75, 130
Nylon
.035" Standard
5
V1420200
2
12
5
V143020
8
12
5
V143580
ULTRAVERSE® RX Catheter
1.25-7
1.5-30
6
4-5
150, 200
Nylon
.014" Small Vessel
12
5
V1420250
4
12
5
V143040
10
12
5
V1435100
VASCUTRAK® 014 Catheter
2-3.5
2-30
12
5
140
Nylon
.014" Specialty
30
12
5
V1420300
6
12
5
V143060
12
12
5
V1435120
VASCUTRAK 018 Catheter
4-7
2-30
12
5-7
80, 140
Nylon
.018" Specialty
2
12
5
V142520
8
12
5
V143080
15
12
5
V1435150
4
12
5
V142540
10
12
5
V1430100
20
12
5
V1435200
6
12
5
V142560
12
12
5
V1430120
25
12
5
V1435250
30
12
5
V1435300
Length
(cm)
RBP*
(ATM)
Sheath
(F)
150 cm
Product Codes
Length
(cm)
RBP*
(ATM)
Sheath
(F)
150 cm
Product Codes
2
12
5
V142020
8
12
5
4
12
6
12
5
V142040
10
12
5
V142060
12
12
8
12
5
V142080
15
10
12
5
V1420100
12
12
5
15
12
20
12
25
CONTINUED >
20
Product
S O L U T I O N S
2.5
3
CONTINUED >
3
3.5
®
®
®
.035" Standard
21
G L O S S A R Y
AV (Arterio-Venous): Products listed with AV indication are for the
treatment of obstructive lesions of native or synthetic arteriovenous
dialysis fistulae.
Nominal (Operating) Pressure: The pressure at which the balloon
reaches its labeled diameter.
RBP (Rated Burst Pressure): The pressure at which the manufacturer
has 95% confidence that 99.9% of balloons will not burst upon single
inflation.
Compliance: The amount of diameter growth in the balloon between
nominal and rated burst pressure.
Most Compliant:
Latex
Semi-Compliant:
Nylon
Non-Compliant:
PET
Ultra Non-Compliant:
Fiber
A compliant balloon will expand in diameter as atmospheres are
increased.
· Compliant balloons may “dogbone or
hourglass” around tight calcified lesions.
· Non-compliant balloons maintain fairly
constant diameter regardless of pressure and
will not stretch or dogbone around a lesion.
· Ultra non-compliant balloons have the least
amount of growth between nominal and RBP,
concentrating pressure against the lesion.
Compliance charts are not required.
NOTE: Compliance should not be confused with “balloon waist” during
inflation, which is normal for all types of balloons.
Pushability: Ability to successfully push catheter to the lesion.
Trackability: Ease at which catheter tracks over the guidewire in
straight or angled anatomy.
MATERIAL
Fiber: The most non-compliant material due to a
strong fiber pattern created from individual strands
of material.
PET / PE blend: Polyethylene tere­­­­ph­thalate.
Nylon: More compliant material than PET but more
puncture resistant.
CATHETER SHAFT
Coaxial: A coaxial shaft has a large inflation lumen and a
guidewire lumen. This design allows the balloon to hold
greater pressure than a multi-lumen catheter and
decreases likelihood of shaft rupture due to high pressures.
It also allows for rapid inflation / deflation times while
maintaining good pushability.
Dual Lumen: A dual lumen shaft has an inflation lumen
and a guidewire lumen. Due to the balance between good
trackability / pushability and inflation / deflation times, most
standard balloons have a dual lumen.
Triple Lumen: A triple lumen shaft has two inflation lumens
and a guidewire lumen. Triple lumen shafts allow for good
track­ability / pushability.
Inflation / Deflation Times: Time required to fully inflate and deflate
­balloon to and from rated burst pressure.
Inflation / deflation time is directly related to shaft working length (cm),
22
O F
T E R M S
A D D I T I O N A L
diameter, and type (e.g., coaxial). Inflation / deflation times will increase
with longer shaft working length, smaller shaft diameter and dual / triple
lumen.
Over the Wire: Wire enters shaft through proximal y-adapter and exits
through the tip
of the balloon.
wire
wire
RX (Rapid Exchange): Wire enters shaft proximal to balloon and exits
through tip.
wire
wire
Working Length: Shaft length (cm) from bifurcate to tip of balloon.
Total Length: Working length plus the additional length outside the
sheath.
Guidewire Length: Should be twice the total length of the balloon to
facilitate loading product without losing access (for OTW; this rule does
not apply to RX as the guidewire can be shorter).
BALLOON CONE / SHOULDERS
Balloon Cone Angle: Angle between
the guidewire lumen and the portion of
the balloon coming off the shaft and tip
(balloon shoulders). A shallow cone angle
Balloon Cone/ offers a more gradual taper, smaller
Balloon Cone/
Shoulders
Shoulders
sheath compatibility and longer cone.
Balloon Cone Length: Horizontal distance from end of balloon to
balloon shoulders.
Balloon Working Length: Horizontal distance between the shoulders
of the balloon.
PROFILE
Crossing Profile: The diameter of the largest balloon profile along the
distal half of the length of the deflated balloon and at the catheter tip
(including the inner member or wire).
Introducer Sheath Profile: The internal diameter of the introducer. It is
important to ensure that the catheter shaft outer diameter is less than
the Introducer Sheath Profile in order to assure compatibility.
Tip Entry Profile: The diameter at the most distal portion of the tip of
the balloon.
Rupture Mode: The manner in which a balloon bursts.
Pin Hole Rupture: Fiber-based balloons may rupture with a small hole
in its material. Other materials often do not have this type of rupture
because the material is more likely to rip, since it is not supported by
fiber.
Longitudinal Rupture: A rip that runs lengthwise on the balloon.
Circumferential Rupture: A rip that encircles the balloon. This is the
most catastrophic type of rupture due to its risk of balloon material
separation and embolization.
ATLAS ® PTA Dilatation Catheter
Indications for Use: ATLAS ® PTA Balloon Dilatation Catheters are
recommended for use in Percutaneous Transluminal Angioplasty of the
iliac arteries and for the treatment of obstructive lesions of native or
synthetic arteriovenous dialysis fistulae. This catheter is not for use in
coronary arteries.
Contraindications: None known.
Warnings: 1) Contents supplied STERILE using ethylene oxide (EO).
Non-Pyrogenic. Do not use if sterile barrier is opened or damaged. Single
patient use only. Do not reuse, reprocess or re-sterilize. 2) This device
has been designed for single use only. Reusing this medical device bears
the risk of cross-patient contamination as medical devices - particularly
those with long and small lumina, joints, and/or crevices between
components - are difficult or impossible to clean once body fluids or
tissues with potential pyrogenic or microbial contamination have had
contact with the medical device for an indeterminable period of time.
The residue of biological material can promote the contamination of the
device with pyrogens or microorganisms which may lead to infectious
complications. 3) Do not resterilize. After resterilization, the sterility of
the product is not guaranteed because of an indeterminable degree
of potential pyrogenic or microbial contamination which may lead to
infectious complications. Cleaning, reprocessing and/or resterilization
of the present medical device increases the probability that the device
will malfunction due to potential adverse effects on components that
are influenced by thermal and/or mechanical changes. 4) To reduce
the potential for vessel damage, the inflated diameter and length of the
balloon should approximate the diameter and length of the vessel just
proximal and distal to the stenosis. 5) When the catheter is exposed to
the vascular system, it should be manipulated while under high-quality
fluoroscopic observation. Do not advance or retract the catheter unless
the balloon is fully deflated. If resistance is met during manipulation,
determine the cause of the resistance before proceeding. Applying
excessive force to the catheter can result in tip breakage or balloon
separation. 6) Do not exceed the RBP recommended for this device.
Balloon rupture may occur if the RBP rating is exceeded. To prevent over
pressurization, use of a pressure monitoring device is recommended.
7) After use, this product may be a potential biohazard. Handle and
dispose of in accordance with acceptable medical practices and
applicable local, state and federal laws and regulations.
Precautions: 1) Carefully inspect the catheter prior to use to verify that
catheter has not been damaged during shipment and that its size, shape
and condition are suitable for the procedure for which it is to be used.
Do not use if product damage is evident. 2) The ATLAS ® catheter shall
only be used by physicians trained in the performance of percutaneous
transluminal angioplasty. 3) The minimal acceptable sheath French size
is printed on the package label. Do not attempt to pass the PTA catheter
through a smaller size sheath introducer than indicated on the label.
4) Use the recommended balloon inflation medium. Never use air or
other gaseous medium to inflate the balloon. 5) If resistance is felt
during post procedure withdrawal of the catheter, it is recommended
to remove the balloon catheter and guidewire/introducer sheath as a
single unit. 6) Do not continue to use the balloon catheter if the shaft
has been bent or kinked. 7) Prior to re-insertion through the introducer
sheath, the balloon should be wiped clean with gauze, rinsed with
sterile normal saline, and refolded with the balloon re-wrap tool. Balloon
re-wrapping should only occur while the balloon catheter is supported
with a guidewire.
Potential Adverse Reactions: The complications which may result
from a peripheral balloon dilatation procedure include: Additional
intervention · Allergic reaction to drugs or contrast medium · Aneurysm
or pseudoaneurysm · Arrhythmias · Embolization · Hematoma
· Hemorrhage, including bleeding at the puncture site · Hypotension/
hypertension · Inflammation · Occlusion · Pain or tenderness
· Pneumothorax or hemothorax · Sepsis/infection · Shock · Short term
hemodynamic deterioration · Stroke · Thrombosis · Vessel dissection,
perforation, rupture, or spasm
Warning: Do not exceed RBP as balloon rupture may occur. To
prevent over pressurization, use of a pressure monitoring device is
recommended.
Please consult package insert for more detailed safety
information and instructions for use.
ATLAS ® Gold PTA Dilatation Catheter
Indications for Use: ATLAS ® Gold PTA Dilatation Catheter is indicated
for use in Percutaneous Transluminal Angioplasty of the iliac arteries
and for the treatment of obstructive lesions of native or synthetic
arteriovenous dialysis fistulae. This device is also indicated for postdilatation of stents and stent grafts in the peripheral vasculature. This
catheter is not for use in coronary arteries.
Contraindications: None known.
Warnings: 1) Contents supplied STERILE using ethylene oxide (EO).
Non-Pyrogenic. Do not use if sterile barrier is opened or damaged.
Single patient use only. Do not reuse, reprocess, or re-sterilize. 2) This
device has been designed for single use only. Reusing this medical
device bears the risk of cross-patient contamination as medical devices
– particularly those with long and small lumina, joints, and/or crevices
between components – are difficult or impossible to clean once body
fluids or tissues with potential pyrogenic or microbial contamination
have had contact with the medical device for an indeterminable period of
time. The residue of biological material can promote the contamination
of the device with pyrogens or microorganisms which may lead to
infectious complications. 3) Do not resterilize. After resterilization, the
sterility of the product is not guaranteed because of an indeterminable
degree of potential pyrogenic or microbial contamination which may
lead to infectious complications. Cleaning, reprocessing, and/or
P R O D U C T
I N F O R M A T I O N
resterilization of the present medical device increases the probability
that the device will malfunction due to potential adverse effects
on components that are influenced by thermal and/or mechanical
changes. 4) To reduce the potential for vessel damage, the inflated
diameter and length of the balloon should approximate the diameter
and length of the vessel just proximal and distal to the stenosis. 5)
To reduce the potential for stent or stent graft damage and/or vessel
damage from the stent or stent graft, the diameter of the balloon should
be no greater than the diameter of the stent or stent graft. Refer to the
stent or stent graft IFU for safety information including the WARNINGS,
PRECAUTIONS, and potential ADVERSE EFFECTS regarding the use of
balloon post-dilatation. 6) When the catheter is exposed to the vascular
system, it should be manipulated while under high-quality fluoroscopic
observation. Do not advance or retract the catheter unless the balloon
is fully deflated. If resistance is met during manipulation, determine the
cause of the resistance before proceeding. Applying excessive force
to the catheter can result in tip breakage or balloon separation. 7) Do
not exceed the RBP recommended for this device. Balloon rupture may
occur if the RBP rating is exceeded. To prevent over pressurization,
use of a pressure monitoring device is recommended. 8) After use,
this product may be a potential biohazard. Handle and dispose of in
accordance with acceptable medical practices and applicable local,
state, and federal laws and regulations.
Precautions: 1) Carefully inspect the catheter prior to use to verify
that catheter has not been damaged during shipment and that its size,
shape, and condition are suitable for the procedure for which it is to
be used. Do not use if product damage is evident. 2) The ATLAS ® Gold
Catheter shall only be used by physicians trained in the performance
of Percutaneous Transluminal Angioplasty. 3) The minimal acceptable
sheath French size is printed on the package label. Do not attempt to
pass the PTA catheter through a smaller size sheath introducer than
indicated on the label. 4) Do not remove the guidewire in situ to shoot
contrast through the wire lumen or perform a wire exchange. If the wire
is removed while the balloon catheter is situated in tortuous anatomy,
the risk of kinking the catheter is increased. 5) Use the recommended
balloon inflation medium (a range of 30-50% contrast medium/a range
of 50-70% sterile saline solution). It has been shown that a 30/70%
contrast/saline ratio has yielded faster balloon inflation/deflation times.
6) Never use air or other gaseous medium to inflate the balloon. 7)
If resistance is felt during post procedure withdrawal of the catheter
through the introducer sheath, determine if contrast is trapped in
the balloon with fluoroscopy. If contrast is present, push the balloon
out of the sheath and then completely evacuate the contrast before
proceeding to withdraw the balloon. 8) If resistance is still felt during
post procedure withdrawal of the catheter, it is recommended to remove
the balloon catheter and guidewire/introducer sheath as a single unit.
9) Do not continue to use the balloon catheter if the shaft has been
bent or kinked. 10) Prior to re-insertion through the introducer sheath,
the balloon should be wiped clean with gauze, rinsed with sterile
normal saline, and refolded with the balloon re-wrap tool. Balloon rewrapping should only occur while the balloon catheter is supported with
a guidewire.
Potential Adverse Reactions: The complications which may result
from a peripheral balloon dilatation procedure include: Additional
intervention · Allergic reaction to drugs or contrast medium · Aneurysm
or pseudoaneurysm · Arrhythmias · Embolization · Hematoma
· Hemorrhage, including bleeding at the puncture site · Hypotension/
hypertension · Inflammation · Occlusion · Pain or tenderness
· Pneumothorax or hemothorax · Sepsis/infection · Shock · Short term
hemodynamic deterioration · Stroke · Thrombosis · Vessel dissection,
perforation, rupture, or spasm
Warning: Do not exceed RBP as balloon rupture may occur. To prevent
over pressurization, use of a pressure monitoring device is
recommended.
Please consult package insert for more detailed safety
information and instructions for use.
C ONQUEST® PTA Dilatation Catheter
Indications for Use: C ONQUEST® PTA Balloon Dilatation Catheter is
recommended for use in Percutaneous Transluminal Angioplasty of the
femoral, iliac, and renal arteries and for the treatment of obstructive
lesions of native or synthetic arteriovenous dialysis fistulae. This device
is also recommended for post-dilatation of stent grafts in the peripheral
vasculature. This catheter is not for use in coronary arteries.
Contraindications: None known.
Warnings: 1) Contents supplied STERILE using ethylene oxide (EO).
Non-Pyrogenic. Do not use if sterile barrier is opened or damaged.
Single patient use only. Do not reuse, reprocess or re-sterilize. 2) This
device has been designed for single use only. Reusing this medical
device bears the risk of cross-patient contamination as medical devices
– particularly those with long and small lumina, joints, and/or crevices
between components – are difficult or impossible to clean once body
fluids or tissues with potential pyrogenic or microbial contamination have
had contact with the medical device for an indeterminable period of time.
The residue of biological material can promote the contamination of the
device with pyrogens or microorganisms which may lead to infectious
complications. 3) Do not resterilize. After resterilization, the sterility of
the product is not guaranteed because of an indeterminable degree
of potential pyrogenic or microbial contamination which may lead to
infectious complications. Cleaning, reprocessing and/or resterilization
of the present medical device increases the probability that the device
will malfunction due to potential adverse effects on components that
are influenced by thermal and/or mechanical changes. 4) To reduce
the potential for vessel damage, the inflated diameter and length of the
balloon should approximate the diameter and length of the vessel just
proximal and distal to the stenosis. 5) When the catheter is exposed to
the vascular system, it should be manipulated while under high-quality
fluoroscopic observation. Do not advance or retract the catheter unless
the balloon is fully deflated. If resistance is met during manipulation,
determine the cause of the resistance before proceeding. Applying
excessive force to the catheter can result in tip breakage or balloon
separation. 6) Do not exceed the RBP recommended for this device.
Balloon rupture may occur if the RBP rating is exceeded. To prevent over
pressurization, use of a pressure monitoring device is recommended.
7) After use, this product may be a potential biohazard. Handle and
dispose of in accordance with acceptable medical practices and
applicable local, state and federal laws and regulations.
Precautions: 1) Carefully inspect the catheter prior to use to verify that
catheter has not been damaged during shipment and that its size, shape
and condition are suitable for the procedure for which it is to be used. Do
not use if product damage is evident. 2) The C ONQUEST® catheter shall
only be used by physicians trained in the performance of percutaneous
transluminal angioplasty. 3) The minimal acceptable sheath French size
is printed on the package label. Do not attempt to pass the PTA catheter
through a smaller size sheath introducer than indicated on the label.
4) Use the recommended balloon inflation medium. Never use air or
other gaseous medium to inflate the balloon. 5) If resistance is felt during
post procedure withdrawal of the catheter, it is recommended to remove
the balloon catheter and guidewire/introducer sheath as a single unit.
6) Do not continue to use the balloon catheter if the shaft has been
bent or kinked. 7) Prior to re-insertion through the introducer sheath,
the balloon should be wiped clean with gauze, rinsed with sterile
normal saline, and refolded with the balloon re-wrap tool. Balloon rewrapping should only occur while the balloon catheter is supported with
a guidewire..
Potential Adverse Reactions: The complications which may result
from a peripheral balloon dilatation procedure include: · Additional
intervention · Allergic reaction to drugs or contrast medium · Aneurysm
or pseudoaneurysm · Arrhythmias · Embolization · Hematoma
· Hemorrhage, including bleeding at the puncture site · Hypotension/
hypertension · Inflammation · Occlusion · Pain or tenderness
· Pneumothorax or hemothorax · Sepsis/infection · Shock · Short term
hemodynamic deterioration · Stroke · Thrombosis · Vessel dissection,
perforation, rupture, or spasm.
Warning: Do not exceed RBP as balloon rupture may occur. To
prevent over pressurization, use of a pressure monitoring device is
recommended.
Please consult package insert for more detailed safety
information and instructions for use.
C ONQUEST® 40 PTA Dilatation Catheter
Indications for Use: C ONQUEST® 40 PTA Dilatation Catheter is
recommended for use in Percutaneous Transluminal Angioplasty of the
femoral, iliac, and renal arteries and for the treatment of obstructive
lesions of native or synthetic arteriovenous dialysis fistulae. This device
is also recommended for post-dilatation of stents and stent grafts in the
peripheral vasculature. This catheter is not for use in coronary arteries.
Contraindications: None known.
Warnings: 1) Contents supplied STERILE using ethylene oxide (EO).
Non-Pyrogenic. Do not use if sterile barrier is opened or damaged.
Single patient use only. Do not reuse, reprocess or re-sterilize. 2) This
device has been designed for single use only. Reusing this medical
device bears the risk of cross-patient contamination as medical devices
– particularly those with long and small lumina, joints, and/or crevices
between components – are difficult or impossible to clean once body
fluids or tissues with potential pyrogenic or microbial contamination
have had contact with the medical device for an indeterminable period of
time. The residue of biological material can promote the contamination
of the device with pyrogens or microorganisms which may lead to
infectious complications. 3) Do not resterilize. After resterilization, the
sterility of the product is not guaranteed because of an indeterminable
degree of potential pyrogenic or microbial contamination which may
lead to infectious complications. Cleaning, reprocessing and/or
resterilization of the present medical device increases the probability
that the device will malfunction due to potential adverse effects
on components that are influenced by thermal and/or mechanical
changes. 4) To reduce the potential for vessel damage, the inflated
diameter and length of the balloon should approximate the diameter
and length of the vessel just proximal and distal to the stenosis. 5)
To reduce the potential for stent or stent graft damage and/or vessel
damage from the stent or stent graft, the diameter of the balloon should
be no greater than the diameter of the stent or stent graft. Refer to the
stent or stent graft IFU for safety information including the WARNINGS,
PRECAUTIONS and potential ADVERSE EFFECTS regarding the use of
balloon post-dilatation. 6) When the catheter is exposed to the vascular
system, it should be manipulated while under high-quality fluoroscopic
observation. Do not advance or retract the catheter unless the balloon
is fully deflated. If resistance is met during manipulation, determine the
cause of the resistance before proceeding. Applying excessive force
to the catheter can result in tip breakage or balloon separation. 7) Do
not exceed the RBP recommended for this device. Balloon rupture may
occur if the RBP rating is exceeded. To prevent over pressurization, use
of a pressure monitoring device is recommended or the use of indicated
syringes. 8) After use, this product may be a potential biohazard.
Handle and dispose of in accordance with acceptable medical practices
and applicable local, state and federal laws and regulations.
Precautions: 1) Carefully inspect the catheter prior to use to verify
that catheter has not been damaged during shipment and that its size,
shape and condition are suitable for the procedure for which it is to be
used. Do not use if product damage is evident. 2) The C ONQUEST® 40
catheter shall only be used by physicians trained in the performance
of percutaneous transluminal angioplasty. 3) The minimal acceptable
23
A D D I T I O N A L
sheath French size is printed on the package label. Do not attempt to
pass the PTA catheter through a smaller size sheath introducer than
indicated on the label. 4) Do not remove the guidewire in situ to shoot
contrast through the wire lumen or perform a wire exchange. If the wire
is removed while the balloon catheter is situated in tortuous anatomy,
the risk of kinking the catheter is increased. 5) Use the recommended
balloon inflation medium (a range of 30-50% contrast medium/a range
of 50-70% sterile saline solution). It has been shown that a 30/70%
contrast / saline ratio has yielded faster balloon inflation / deflation
times. 6) Never use air or other gaseous medium to inflate the balloon.
7) If resistance is felt during post procedure withdrawal of the catheter
through the introducer sheath, determine if contrast is trapped in
the balloon with fluoroscopy. If contrast is present, push the balloon
out of the sheath and then completely evacuate the contrast before
proceeding to withdraw the balloon. 8) If resistance is still felt during
post procedure withdrawal of the catheter, it is recommended to remove
the balloon catheter and guidewire/introducer sheath as a single unit.
9) Do not continue to use the balloon catheter if the shaft has been bent
or kinked. 10) Prior to re-insertion through the introducer sheath, the
balloon should be wiped clean with gauze, rinsed with sterile normal
saline, and refolded with the balloon re-wrap tool. Balloon re-wrapping
should only occur while the balloon catheter is supported with a
guidewire or stylet.
Potential Adverse Reactions: The complications which may result
from a peripheral balloon dilatation procedure include: Additional
intervention · Allergic reaction to drugs or contrast medium
· Aneurysm or pseudoaneurysm · Arrhythmias · Embolization
· Hematoma · Hemorrhage, including bleeding at the puncture
site · Hypotension/hypertension · Inflammation · Occlusion · Pain
or tenderness · Pneumothorax or hemothorax · Sepsis/infection ·
Shock · Short term hemodynamic deterioration · Thrombosis · Vessel
dissection, perforation, rupture, or spasm
Warning: Do not exceed the RBP recommended for this device.
Balloon rupture may occur if the RBP rating is exceeded. To prevent
over pressurization, use of a pressure monitoring device or indicated
syringe is recommended.
Please consult package insert for more detailed safety
information and instructions for use.
DORADO® Balloon Dilatation Catheter
Indications for Use: D ORADO ® Balloon Dilatation Catheters are
recommended for Percutaneous Transluminal Angioplasty (PTA) of the
renal, iliac, femoral, popliteal, tibial, peroneal, and subclavian arteries
and for the treatment of obstructive lesions of native or synthetic
arteriovenous dialysis fistulae. This device is also recommended for
post-dilatation of balloon expandable and self expanding stents in the
peripheral vasculature. This catheter is not for use in coronary arteries.
Contraindications: None known.
Warnings: 1) Contents supplied STERILE using ethylene oxide (EO).
Non-pyrogenic. Do not use if sterile barrier is opened or damaged.
Single patient use only. Do not reuse, reprocess or re-sterilize. 2) This
device has been designed for single use only. Reusing this medical
device bears the risk of cross-patient contamination as medical devices
– particularly those with long and small lumina, joints, and/or crevices
between components – are difficult or impossible to clean once body
fluids or tissues with potential pyrogenic or microbial contamination
have had contact with the medical device for an indeterminable period of
time. The residue of biological material can promote the contamination
of the device with pyrogens or microorganisms which may lead to
infectious complications. 3) Do not resterilize. After resterilization, the
sterility of the product is not guaranteed because of an indeterminable
degree of potential pyrogenic or microbial contamination which may
lead to infectious complications. Cleaning, reprocessing and/or
resterilization of the present medical device increases the probability
that the device will malfunction due to potential adverse effects on
components that are influenced by thermal and/or mechanical changes.
4) To reduce the potential for vessel damage, the inflated diameter and
length of the balloon should approximate the diameter and length of the
vessel just proximal and distal to the stenosis. 5) When the catheter is
exposed to the vascular system, it should be manipulated while under
high-quality fluoroscopic observation. Do not advance or retract the
catheter unless the balloon is fully deflated. If resistance is met during
manipulation, determine the cause of the resistance before proceeding.
Applying excessive force to the catheter can result in tip breakage or
balloon separation. 6) Do not exceed the RBP recommended for this
device. Balloon rupture may occur if the RBP rating is exceeded. To
prevent overpressurization, use of a pressure monitoring device is
recommended. 7) After use, this product may be a potential biohazard.
Handle and dispose of in accordance with acceptable medical practices
and applicable local, state and federal laws and regulations.
Precautions: 1) Carefully inspect the catheter prior to use to verify that
catheter has not been damaged during shipment and that its size, shape
and condition are suitable for the procedure for which it is to be used.
Do not use if product damage is evident. 2) The D ORADO ® catheter shall
only be used by physicians trained in the performance of percutaneous
transluminal angioplasty. 3) The minimal acceptable sheath French size
is printed on the package label. Do not attempt to pass the PTA catheter
through a smaller size sheath introducer than indicated on the label.
4) Do not remove the guidewire in situ to shoot contrast through the
wire lumen or perform a wire exchange. If the wire is removed while
the balloon catheter is situated in tortuous anatomy, the risk of kinking
the catheter is increased. 5) Use the recommended balloon inflation
medium (a range of 30-50% contrast medium/a range of 50-70%
sterile saline solution). It has been shown that a 30/70% contrast/saline
ratio has yielded faster balloon inflation/deflation times. Never use air
or other gaseous medium to inflate the balloon. 6) If resistance is felt
24
P R O D U C T
I N F O R M A T I O N
during post-procedure withdrawal of the catheter through the introducer
sheath, determine if contrast is trapped in the balloon with fluoroscopy.
If contrast is present, push the balloon out of the sheath and then
completely evacuate the contrast before proceeding to withdraw the
balloon. 7) If resistance is still felt during post-procedure withdrawal
of the catheter, it is recommended to remove the balloon catheter and
guidewire/introducer sheath as a single unit. 8) Do not continue to use
the balloon catheter if the shaft has been bent or kinked. 9) Prior to
re-insertion through the introducer sheath, the balloon should be wiped
clean with gauze, rinsed with sterile normal saline, and refolded with the
balloon re-wrap tool. Balloon re-wrapping should only occur while the
balloon catheter is supported with a guidewire or stylet.
Potential Adverse Reactions: The complications which may result
from a peripheral balloon dilatation procedure include: · Additional
intervention · Allergic reaction to drugs or contrast medium
· Aneurysm or pseudoaneurysm · Arrhythmias · Embolization
· Hematoma · Hemorrhage, including bleeding at the puncture
site · Hypotension/hypertension · Inflammation · Occlusion · Pain
or tenderness · Pneumothorax or hemothorax · Sepsis/infection
· Shock · Short-term hemodynamic deterioration · Stroke
· Thrombosis · Vessel dissection, perforation, rupture, or spasm.
Please consult package insert for more detailed safety
information and instructions for use.
L UTONIX® 035 Drug Coated Balloon PTA Catheter
Indications for Use: The L UTONIX® 035 Drug Coated Balloon PTA
catheter is indicated for percutaneous transluminal angioplasty, after
appropriate vessel preparation, of de novo or restenotic lesions up to
150 mm in length in native superficial femoral or popliteal arteries with
reference vessel diameters of 4-7 mm.
Contraindications: The L UTONIX® Catheter is contraindicated for use
in: 1) Patients who cannot receive recommended anti-platelet and/or
anticoagulant therapy. 2) Women who are breastfeeding, pregnant or
are intending to become pregnant or men intending to father children. It
is unknown whether paclitaxel will be excreted in human milk and there
is a potential for adverse reaction in nursing infants from paclitaxel
exposure. 3) Patients judged to have a lesion that prevents complete
inflation of an angioplasty balloon or proper placement of the delivery
system.
Warnings: 1) Contents supplied STERILE using ethylene oxide (EO)
process. Do not use if sterile barrier is damaged or opened prior to
intended use. 2) Do not use if product damage is evident. 3) The
L UTONIX® Catheter is for use in one patient only; do not reuse in another
patient, reprocess or resterilize. Risks of reuse in another patient,
reprocessing, or resterilization include: – Compromising the structural
integrity of the device and/or device failure which, in turn, may result in
patient injury, illness or death. – Creating a risk of device contamination
and/or patient infection or cross-infection, including, but not limited to,
the transmission of infectious disease(s) from one patient to another.
Contamination of the device may lead to patient injury, illness or death.
4) Do not exceed the Rated Burst Pressure (RBP) recommended for
this device. Balloon rupture may occur if the RBP rating is exceeded.
To prevent over-pressurization, use of a pressure monitoring device
is recommended. 5) Use the recommended balloon inflation medium
of contrast and sterile saline (≤50% contrast). Never use air or any
gaseous medium to inflate the balloon. 6) This product should not be
used in patients with known hypersensitivity to paclitaxel or structurally
related compounds. 7) The safety and effectiveness of the L UTONIX®
Catheter have not been established for treatment in cerebral, carotid,
coronary, or renal vasculature. 8) The safety and effectiveness of using
more than two L UTONIX® drug coated balloons (i.e., a maximum drug
coating quantity of approximately 7.6 mg paclitaxel) in a patient has not
been clinically evaluated.
Precautions: General Precautions: 1) The L UTONIX® Catheter should
only be used by physicians trained in percutaneous interventional
procedures. 2) Consideration should be given to the risks and benefits
of use in patients with a history of non-controllable allergies to contrast
agents.
Potential Adverse Events: Potential adverse events which may be
associated with a peripheral balloon dilatation procedure include:
Additional intervention · Allergic reaction to drugs, excipients, or contrast
medium · Amputation/loss of limb · Aneurysm or pseudoaneurysm
· Arrythmias · Embolization · Hematoma · Hemorrhage, including
bleeding at the puncture site · Hypotension/hypertension · Inflammation
· Occlusion · Pain or tenderness · Pneumothorax or hemothorax ·
Sepsis/infection · Shock · Stroke · Thrombosis · Vessel dissection,
perforation, rupture, or spasm
Although systemic effects are not anticipated, refer to the Physicians’
Desk Reference for more information on the potential adverse events
observed with paclitaxel.
Potential adverse events, not described in the above source, which may
be unique to the paclitaxel drug coating include: Allergic/immunologic
reaction to the drug coating (paclitaxel) · Alopecia · Anemia ·
Blood product transfusion · Gastrointestinal symptoms · Hematologic
dyscrasia (including leukopenia, neutropenia, thrombocytopenia) ·
Hepatic enzyme changes · Histologic changes in vessel wall, including
inflammation, cellular damage, or necrosis · Myalgia/Arthralgia ·
Myelosuppression · Peripheral neuropathy
Please consult product labels and instructions for use for
indications, contraindications, hazards, warnings and
precautions.
P RESTO™ Inflation Device
Indications for Use: The P RESTO™ Inflation Device is indicated for use
with angioplasty balloon dilatation catheters to create and monitor the
pressure in the angioplasty balloon dilatation catheter and to deflate the
angioplasty balloon dilatation catheter.
Contraindications: None known.
Warnings: 1) Contents supplied STERILE using ethylene oxide (EO).
Non-Pyrogenic. Do not use if sterile barrier is opened or damaged.
Single patient use only. Do not reuse, reprocess or re-sterilize. 2) This
device has been designed for single use only. Reusing this medical
device bears the risk of cross-patient contamination as medical devices
– particularly those with long and small lumina, joints, and/or crevices
between components – are difficult or impossible to clean once body
fluids or tissues with potential pyrogenic or microbial contamination
have had contact with the medical device for an indeterminable period of
time. The residue of biological material can promote the contamination
of the device with pyrogens or microorganisms which may lead to
infectious complications. 3) Do not resterilize. After resterilization, the
sterility of the device is not guaranteed because of an indeterminable
degree of potential pyrogenic or microbial contamination which may
lead to infectious complications. Cleaning, reprocessing and/or
resterilization of the present medical device increases the probability
that the device will malfunction due to potential adverse effects
on components that are influenced by thermal and/or mechanical
changes. 4) After use, this device may be a potential biohazard. Handle
and dispose of in accordance with acceptable medical practices and
applicable local, state and federal laws and regulations. 5) To reduce
the potential risk of air embolism, never use air or other gaseous
medium to inflate angioplasty balloon dilatation catheters. Ensure all air
has been purged from the entire fluid path prior to patient use. 6) Do not
exceed 40 ATM when inflating the device. Damage to the device or user
injury may result. 7) Refer to the angioplasty balloon dilatation catheter
instructions for use for additional warnings.
Precautions: 1) Carefully inspect the device prior to use to verify that
it has not been damaged during shipment. Do not use if device damage
is evident. 2) Discontinue use of the device if damage, malfunction or
contamination is suspected during use. 3) For experienced physician
use only. 4) Refer to the angioplasty balloon dilatation catheter
instructions for use for additional precautions.
Please consult product labels and instructions for use, indications,
contraindications, hazards, warnings, and precautions.
U LTRAVERSE® 035 PTA Balloon Dilatation Catheter
Indications for Use: The U LTRAVERSE® 035 PTA Balloon Dilatation
Catheter is intended to dilate stenoses in the peripheral arteries, to treat
obstructive lesions of native or synthetic A-V fistulae and/or re-expand
endoluminal stent graft elements in the iliac arteries. This device is
also recommended for post-dilatation of balloon expandable and selfexpanding stents in the peripheral vasculature. This catheter is not for
use in coronary arteries.
Contraindications: None known.
Warnings: 1) Contents supplied STERILE using ethylene oxide (EO).
Non-Pyrogenic. Do not use if sterile barrier is opened or damaged. Do
not reuse, reprocess or resterilize. 2) This device has been designed
for single use only. Reusing this medical device bears the risk of crosspatient contamination as medical devices – particularly those with long
and small lumina, joints, and/or crevices between components – are
difficult or impossible to clean once body fluids or tissues with potential
pyrogenic or microbial contamination have had contact with the medical
device for an indeterminable period of time. The residue of biological
material can promote the contamination of the device with pyrogens
or microorganisms which may lead to infectious complications. 3) Do
not resterilize. After resterilization, the sterility of the product is not
guaranteed because of an indeterminable degree of potential pyrogenic
or microbial contamination, which may lead to infectious complications.
Cleaning, reprocessing, and/or resterilization of the present medical
device increases the probability that the device will malfunction due
to potential adverse effects on components that are influenced by
thermal and/or mechanical changes. 4) To reduce the potential for
vessel damage, the inflated diameter and length of the balloon should
approximate the diameter and length of the vessel just proximal and
distal to the stenosis. 5) When the catheter is exposed to the vascular
system, it should be manipulated while under high-quality fluoroscopic
observation. Do not advance or retract the catheter unless the balloon
is fully deflated. If resistance is met during manipulation, determine the
cause of the resistance before proceeding. Applying excessive force
to the catheter can result in tip or catheter breakage, catheter kink,
or balloon separation. 6) Do not exceed the RBP recommended for
this device. Balloon rupture may occur if the RBP rating is exceeded.
To prevent over pressurization, use of a pressure monitoring device is
recommended. 7) After use, this product may be a potential biohazard.
Handle and dispose of in accordance with acceptable medical practices
and applicable local, state, and federal laws and regulations.
Precautions: 1) Carefully inspect the catheter prior to use to verify
that catheter has not been damaged during shipment and that its size,
shape, and condition are suitable for the procedure for which it is to
be used. Do not use if product damage is evident. 2) U LTRAVERSE®
035 shall only be used by physicians experienced in the performance
of percutaneous transluminal angioplasty. 3) The minimal acceptable
introducer sheath/guide catheter French size is printed on the package
label. Do not attempt to pass the PTA catheter through a smaller size
introducer sheath/guide catheter than indicated on the label. 4) Use the
recommended balloon inflation medium (25% contrast medium/75%
sterile saline solution). It has been shown that a 25%/75% contrast/
saline ratio has yielded faster balloon inflation/deflation times. Never
use air or other gaseous medium to inflate the balloon. 5) If resistance
is felt during post procedure withdrawal of the catheter through the
introducer sheath/guide catheter, determine if contrast is trapped in
A D D I T I O N A L
the balloon with fluoroscopy. If contrast is present, push the balloon out
of the introducer sheath/guide catheter and then completely evacuate
the contrast before proceeding to withdraw the balloon. 6) If resistance
is still felt during post procedure withdrawal of the catheter, it is
recommended to remove the balloon catheter and introducer sheath/
guide catheter as a single unit. 7) Do not continue to use the balloon
catheter if the catheter shaft has been bent or kinked. 8) Prior to reinsertion through the introducer sheath/guide catheter, the balloon
should be wiped clean with gauze and rinsed with sterile normal saline.
9) Balloon re-wrapping should only occur while the balloon catheter is
supported with a guidewire or stylet. 10) G EOA LIGN ® Marker Bands are
designed to be used only as an additional reference tool to accompany
the interventionalist standard operation procedure.
Potential Adverse Reactions: The complications that may result
from a peripheral balloon dilatation procedure include: · Additional
intervention · Allergic reaction to drugs or contrast medium · Aneurysm
or pseudoaneurysm · Arrhythmias · Embolization · Hematoma ·
Hemorrhage, including bleeding at the puncture site · Hypotension/
hypertension · Inflammation · Occlusion · Pain or tenderness ·
Pneumothorax or hemothorax · Sepsis/infection · Shock · Short term
hemodynamic deterioration · Stroke · Thrombosis · Vessel dissection,
perforation, rupture, or spasm
Please consult package insert for more detailed safety
information and instructions for use.
U LTRAVERSE® 014/018 PTA Balloon Dilatation Catheters
Indications for Use: U LTRAVERSE® 014 and U LTRAVERSE® 018 PTA
Dilatation Catheters are recommended for use in percutaneous
transluminal angioplasty (PTA) of the renal, popliteal, tibial, femoral and
peroneal arteries. These catheters are not for use in coronary arteries.
Contraindications: None known.
Warnings: 1) Contents supplied STERILE using ethylene oxide (EO).
Non-pyrogenic. Do not use if sterile barrier is opened or damaged. Do
not reuse, reprocess or re-sterilize. 2) This device has been designed
for single use only. Reusing this medical device bears the risk of crosspatient contamination as medical devices – particularly those with long
and small lumina, joints and/or crevices between components – are
difficult or impossible to clean once body fluids or tissues with potential
pyrogenic or microbial contamination have had contact with the medical
device for an indeterminable period of time. The residue of biological
material can promote the contamination of the device with pyrogens
or microorganisms which may lead to infectious complications. 3)Do
not resterilize. After resterilization, the sterility of the product is not
guaranteed because of an indeterminable degree of potential pyrogenic
or microbial contamination which may lead to infectious complications.
Cleaning, reprocessing and/or resterilization of the present medical
device increases the probability that the device will malfunction due
to potential adverse effects on components that are influenced by
thermal and/or mechanical changes. 4) To reduce the potential for
vessel damage, the inflated diameter and length of the balloon should
approximate the diameter and length of the vessel just proximal and
distal to the stenosis. 5) When the catheter is exposed to the vascular
system, it should be manipulated while under high-quality fluoroscopic
observation. Do not advance or retract the catheter unless the balloon
is fully deflated. If resistance is met during manipulation, determine the
cause of the resistance before proceeding. Applying excessive force
to the catheter can result in tip breakage or balloon separation. 6) Do
not exceed the RBP recommended for this device. Balloon rupture may
occur if the RBP rating is exceeded. To prevent over-pressurization,
use of a pressure monitoring device is recommended. 7) After use,
this product may be a potential biohazard. Handle and dispose of in
accordance with acceptable medical practices and applicable local,
state and federal laws and regulations.
Precaution: 1) Carefully inspect the catheter prior to use to verify that
catheter has not been damaged during shipment and that its size, shape
and condition are suitable for the procedure for which it is to be used.
Do not use if product damage is evident. 2) The U LTRAVERSE® 014 and
U LTRAVERSE® 018 PTA Balloon Dilatation Catheters shall only be used
by physicians trained in the performance of percutaneous transluminal
angioplasty. 3) The minimal acceptable sheath French size is printed
on the package label. Do not attempt to pass the PTA catheter through
a smaller size introducer sheath than indicated on the label. Do not
remove the guidewire in situ to shoot contrast through the wire lumen
or perform a wire exchange. If the wire is removed while the balloon
catheter is situated in tortuous anatomy, the risk of kinking the catheter
is increased. 4) Use the recommended balloon inflation medium (25%
contrast medium/75% sterile saline solution). It has been shown that
a 25/75% contrast/saline ratio has yielded faster balloon inflation/
deflation times. Never use air or other gaseous medium to inflate the
balloon. 5) If resistance is felt during post-procedure withdrawal of
the catheter through the introducer sheath, determine if contrast is
trapped in the balloon with fluoroscopy. If contrast is present, push the
balloon out of the sheath and then completely evacuate the contrast
before proceeding to withdraw the balloon. 6) If resistance is still felt
during post-procedure withdrawal of the catheter, it is recommended
to remove the balloon catheter and guidewire/introducer sheath as a
single unit. 7) Do not continue to use the balloon catheter if the shaft
has been bent or kinked. 8) Prior to re-insertion through the introducer
sheath, the balloon should be wiped clean with gauze and rinsed with
sterile normal saline. 9) Balloon re-wrapping should only occur while
the balloon catheter is supported with a guidewire or stylet. 10) In
order to activate the hydrophilic coating, it is recommended to wet the
U LTRAVERSE® Catheter with sterile saline solution immediately prior to
its insertion in the body.
Potential Adverse Reactions: The complications that may result
P R O D U C T
I N F O R M A T I O N
from a peripheral balloon dilatation procedure include: · Additional
intervention · Allergic reaction to drugs or contrast medium · Aneurysm
or pseudoaneurysm · Arrhythmias · Embolization · Hematoma ·
Hemorrhage, including bleeding at the puncture site · Hypotension/
hypertension · Inflammation · Occlusion · Pain or tenderness ·
Pneumothorax or hemothorax · Sepsis/infection · Shock · Short-term
hemodynamic deterioration · Stroke · Thrombosis · Vessel dissection,
perforation, rupture or spasm.
Please consult package insert for more detailed safety
information and instructions for use.
Ultraverse® RX PTA Dilatation Catheter
Indications for Use: U LTRAVERSE® RX PTA Dilatation Catheter is
indicated for use in Percutaneous Transluminal Angioplasty of the renal,
femoral, popliteal and infra-popliteal arteries. This catheter is not for
use in coronary arteries.
Contraindications: None known.
Warnings: 1) Contents supplied STERILE using ethylene oxide (EO).
Non-Pyrogenic. Do not use if sterile barrier is opened or damaged. Do
not reuse, reprocess or resterilize. 2) This device has been designed
for single use only. Reusing this medical device bears the risk of crosspatient contamination as medical devices – particularly those with long
and small lumina, joints, and/or crevices between components – are
difficult or impossible to clean once body fluids or tissues with potential
pyrogenic or microbial contamination have had contact with the medical
device for an indeterminable period of time. The residue of biological
material can promote the contamination of the device with pyrogens
or microorganisms which may lead to infectious complications. 3) Do
not resterilize. After resterilization, the sterility of the product is not
guaranteed because of an indeterminable degree of potential pyrogenic
or microbial contamination which may lead to infectious complications.
Cleaning, reprocessing, and/or resterilization of the present medical
device increases the probability that the device will malfunction due
to potential adverse effects on components that are influenced by
thermal and/or mechanical changes. 4) To reduce the potential for
vessel damage, the inflated diameter and length of the balloon should
approximate the diameter and length of the vessel just proximal and
distal to the stenosis. 5) When the catheter is exposed to the vascular
system, it should be manipulated while under high-quality fluoroscopic
observation. Do not advance or retract the catheter unless the balloon
is fully deflated. If resistance is met during manipulation, determine the
cause of the resistance before proceeding. Applying excessive force
to the catheter can result in tip or catheter breakage, catheter kink,
or balloon separation. 6) Do not exceed the RBP recommended for
this device. Balloon rupture may occur if the RBP rating is exceeded.
To prevent over pressurization, use of a pressure monitoring device is
recommended. 7) After use, this product may be a potential biohazard.
Handle and dispose of in accordance with acceptable medical practices
and applicable local, state, and federal laws and regulations.
Precautions: 1) Carefully inspect the catheter prior to use to verify
that catheter has not been damaged during shipment and that its size,
shape, and condition are suitable for the procedure for which it is to
be used. Do not use if product damage is evident. 2) U LTRAVERSE®
RX Catheter shall only be used by physicians experienced in the
performance of percutaneous transluminal angioplasty. 3) The minimal
acceptable introducer sheath/guide catheter French size is printed on
the package label. Do not attempt to pass the PTA catheter through
a smaller size introducer sheath/guide catheter than indicated on
the label. 4) Use the recommended balloon inflation medium (25%
contrast medium/75% sterile saline solution). It has been shown that
a 25%/75% contrast/saline ratio has yielded faster balloon inflation/
deflation times. Never use air or other gaseous medium to inflate the
balloon. 5) If resistance is felt during post procedure withdrawal of
the catheter through the introducer sheath/guide catheter, determine
if contrast is trapped in the balloon with fluoroscopy. If contrast is
present, push the balloon out of the introducer sheath/guide catheter
and then completely evacuate the contrast before proceeding to
withdraw the balloon. 6) If resistance is still felt during post procedure
withdrawal of the catheter, it is recommended to remove the balloon
catheter and introducer sheath/guide catheter as a single unit. 7) Do
not continue to use the balloon catheter if the catheter shaft has been
bent or kinked. 8) Prior to re-insertion through the introducer sheath/
guide catheter, the balloon should be wiped clean with gauze and rinsed
with sterile normal saline. 9) Balloon re-wrapping should only occur
while the balloon catheter is supported with a guidewire or stylet. 10) In
order to activate the hydrophilic coating, it is recommended to wet the
U LTRAVERSE® RX Catheter with sterile saline solution immediately prior
to its insertion in the body.
Potential Adverse Reaction: The complications which may result
from a peripheral balloon dilatation procedure include: · Additional
intervention · Allergic reaction to drugs or contrast medium · Aneurysm
or pseudoaneurysm · Arrhythmias · Embolization · Hematoma ·
Hemorrhage, including bleeding at the puncture site · Hypotension/
hypertension · Inflammation · Occlusion · Pain or tenderness ·
Pneumothorax or hemothorax · Sepsis/infection · Shock · Short term
hemodynamic deterioration · Stroke · Thrombosis · Vessel dissection,
perforation, rupture, or spasm
Please consult package insert for more detailed safety
information and instructions for use.
device is also recommended for post dilatation of balloon expandable
stents, self-expanding stents, and stent grafts in the peripheral
vasculature.
Contraindications: The VASCUTRAK® PTA Dilatation Catheter is
contraindicated: 1) where there is the inability to cross the target lesion
with a guidewire; 2) for use in the coronary or neuro vasculature.
Warnings: 1) Contents supplied sterile using ethylene oxide (EO). Nonpyrogenic. Do not use if sterile barrier is opened or damaged. Do not
reuse, reprocess or re-sterilize. Use the catheter prior to the “Use By”
date specified on the package label. 2) This device has been designed
for single use only. Reusing this medical device bears the risk of crosspatient contamination as medical devices – particularly those with long
and small lumina, joints and/or crevices between components – are
difficult or impossible to clean once body fluids or tissues with potential
pyrogenic or microbial contamination have had contact with the medical
device for an indeterminable period of time. The residue of biological
material can promote the contamination of the device with pyrogens or
microorganisms, which may lead to infectious complications. 3) Do not
resterilize. After resterilization, the sterility of the product is not
guaranteed because of an indeterminable degree of potential pyrogenic
or microbial contamination, which may lead to infectious complications.
Cleaning, reprocessing and/or resterilization of the present medical
device increases the probability that the device will malfunction due to
potential adverse effects on components that are influenced by thermal
and/or mechanical changes. 4) To reduce the potential for vessel
damage, the inflated diameter and length of the balloon should
approximate the diameter and length of the vessel just proximal and
distal to the stenosis. 5) When the catheter is exposed to the vascular
system, it should be manipulated while under high-quality fluoroscopic
observation. Do not advance or retract the catheter unless the balloon
is fully deflated. If resistance is met during manipulation, determine the
cause of the resistance before proceeding. Applying excessive force to
the catheter can result in tip breakage or balloon separation. 6) Do not
exceed the RBP recommended for this device. Balloon rupture may
occur if the RBP rating is exceeded. To prevent over-pressurization, use
of a pressure monitoring device is recommended. 7) After use, this
product may be a potential biohazard. Handle and dispose of in
accordance with acceptable medical practices and applicable local,
state and federal laws and regulations.
Precautions: 1) Carefully inspect the catheter prior to use to verify that
catheter has not been damaged during shipment and that its size, shape
and condition are suitable for the procedure for which it is to be used.
Do not use if product damage is evident. 2) The VASCUTRAK® PTA
Dilatation Catheter should only be used by physicians trained in the
performance of percutaneous transluminal angioplasty. 3) In order to
activate the hydrophilic coating, wet the VASCUTRAK® balloon and
catheter with sterile saline or wipe the balloon catheter with sterile
saline saturated gauze immediately prior to its insertion in the body. Do
not wipe the balloon catheter with dry gauze. 4) When backloading the
catheter onto the guidewire, support the catheter and ensure that the
guidewire tip does not snag or come into contact with the balloon.
5) The minimal acceptable sheath French size is printed on the package
label. Do not attempt to pass the PTA catheter through a smaller size
introducer sheath than indicated on the label. 6) Use the recommended
balloon inflation medium (50% contrast medium/50% sterile saline
solution). It has been shown that a 25/75% contrast/saline ratio has
yielded faster balloon inflation/deflation times. Never use air or other
gaseous medium to inflate the balloon. 7) VASCUTRAK® PTA Dilatation
Catheters should be used with caution for procedures involving calcified
lesions or synthetic vascular grafts due to the abrasive nature of these
lesions. 8) Never attempt to move the guidewire when the balloon is
inflated. 9) Fully evacuate the balloon prior to withdrawing the system.
Larger sizes of VASCUTRAK® balloons may exhibit slower deflation times.
If the balloon does not deflate, advance a sheath or catheter over the
proximal portion of the balloon to straighten out the transition from
connection of the balloon to the inflation lumen. 10) If resistance is felt
during post-procedure withdrawal of the catheter through the introducer
sheath, determine if contrast medium is trapped in the balloon with
fluoroscopy. If contrast is present, push the balloon out of the sheath
and then completely evacuate the contrast before proceeding to
withdraw the balloon. 11) If resistance is still felt during post-procedure
withdrawal of the catheter, it is recommended to remove the balloon
catheter and guidewire/ introducer sheath as a single unit. 12) Do not
continue to use the balloon catheter if the shaft has been bent or kinked.
13) Prior to re-insertion through the introducer sheath, re-activate the
hydrophilic coating and clean the balloon catheter by wiping the balloon
catheter with sterile saline saturated gauze and rinsing with sterile
saline. Do not wipe the balloon catheter with dry gauze.
Potential Adverse Reactions: The complications that may result from
a peripheral balloon dilatation procedure include: · Additional
intervention · Allergic reaction to drugs or contrast medium · Aneurysm
or pseudoaneurysm · Arrhythmias · Embolization · Hematoma ·
Hemorrhage, including bleeding at the puncture site · Hypotension/
hypertension · Inflammation · Occlusion · Pain or tenderness ·
Pneumothorax or hemothorax · Sepsis/infection · Shock · Short-term
hemodynamic deterioration · Stroke · Thrombosis · Vessel dissection,
perforation, rupture or spasm.
Please consult package insert for more detailed safety
information and instructions for use.
VASCUTRAK® PTA Dilatation Catheter
Indications for Use: The VASCUTRAK® PTA Dilatation Catheter is
intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal,
infra-popliteal and renal arteries and for the treatment of obstructive
lesions of native or synthetic arterioveneous dialysis fistulae. This
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