Download A Step Ahead in SFA Treatment L Why 035

A Step Ahead in SFA Treatment
Why Lutonix 035
®
The Lutonix® 035 difference is in our unique,
proprietary formulation and coating, designed to
maximize efficacy without compromising safety,
as demonstrated through rigorously conducted
clinical trials.
Proven Efficacy
Uniform drug delivery from in vivo administration of fluorescent-labeled Lutonix®
035 DCB Catheter, harvested one hour after delivery.1
Proven Formulation and Coating
More than 250 formulations, 50,000 balloons, and
45 pre-clinical studies went into the development
of the Lutonix® 035 DCB Catheter formulation
and coating. The formulation is scientifically
engineered to deliver an optimal therapeutic dose
at the drug treatment site.
· Delivers an optimal therapeutic dose, utilizing
a paclitaxel concentration of 2 µg/mm2
· Scientifically designed to achieve high drug
retention on the balloon during preparation
and handling
· Uniform, transfer-efficient coating optimizes
drug delivery and uptake1
The Lutonix® 035 DCB Catheter has been studied
in LEVANT 2, a global, prospective, randomized,
multi-center, rigorous, level 1 clinical trial that
was designed to minimize bias and isolate key
variables.
· Anti-restenotic effects demonstrated in level
1 clinical trial
· In LEVANT 2, Lutonix® 035 demonstrated
similar risks and ease of use as PTA, with
superior primary patency outcomes3
Proven Safety
The Lutonix® 035 DCB Catheter’s safety profile
is comparable with PTA, as proven in LEVANT 1
and LEVANT 2 clinical trials. In LEVANT 2, at 12
months there was no increased risk compared to
PTA observed after treatment with Lutonix® 035 in
major events including amputations, thrombosis,
embolization, reintervention, death and freedom
from loss in patency.3 Its proprietary coating is
designed to:
· Minimize systemic paclitaxel exposure
· Minimize downstream effects
· Ensure durability during preparation and
handling
Bard and Lutonix are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate.
Copyright 2014 C. R. Bard, Inc. All rights reserved.
Advancing Lives and the Delivery of Health Care™
75 cm Catheter Length
.035" Guidewire Compatible
Diameter
(mm)
130 cm Catheter Length
.035" Guidewire Compatible
Length
(mm)
RBP †
(ATM)
Sheath
Profile (F)
40
12
5F
LX3575440
60
12
5F
LX3575460
Diameter
(mm)
Product Codes
4
Length
(mm)
RBP †
(ATM)
Sheath
Profile (F)
40
12
5F
LX35130440
60
12
5F
LX35130460
Product Codes
4
80
12
5F
LX3575480
80
12
5F
LX35130480
100
12
5F
LX35754100
100
12
5F
LX351304100
40
12
5F
LX3575540
40
12
5F
LX35130540
60
12
5F
LX3575560
60
12
5F
LX35130560
5
5
80
12
5F
LX3575580
80
12
5F
LX35130580
100
12
5F
LX35755100
100
12
5F
LX351305100
40
12
6F
LX3575640
40
12
6F
LX35130640
60
12
6F
LX3575660
60
12
6F
LX35130660
6
6
80
12
6F
LX3575680
80
12
6F
LX35130680
100
12
6F
LX35756100
100
12
6F
LX351306100
1 Animal data on file. Bench or pre-clinical data may not be indicative of clinical performance
Nominal Pressure*
2 Rosenfield, et. al The LEVANT I (Lutonix® Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal
Restenosis) Trial for Femoropopliteal Revascularization JACC: Cardiovascular Interventions Vol 7, No. 1, 20143
Bench test data on file. Bench results may not be indicative of clinical performance. Different test methods may
yield different results.
3 LEVANT 2 clinical trial data on file. N=476. At 12 months, treatment with Lutonix® 035 resulted in a primary
patency rate of 73.5% versus 56.8% with PTA alone (p=0.001). Primary patency defined as absence of binary
restenosis defined by DUS PSVR ≥ 2.5 and freedom from Target Lesion Revascularization (TLR). At 12 months,
treatment with Lutonix® 035 resulted in a freedom from primary safety event rate of 86.7% versus 81.5% with
PTA alone. Primary safety defined as composite of freedom from all-cause perioperative death and freedom at 1
year in the index limb from amputation (ATK or BTK), reintervention, and Index-limb related death. Percentages
repoted are derived from Kaplan-Meier analyses, not pre-specified.
4, 5 mm
6 ATM
6 mm
7 ATM
† RBP (Rated Burst Pressure): the pressure at which Bard has 95% confidence that 99.9% of the balloons will not burst at or
below upon single inflation.
* Nominal pressure: the pressure at which the balloon reaches its labeled diameter.
REPRESENTATIVE’S NAME
CONTACT PHONE NO.
PHYSICIAN’S SIGNATURE
Lutonix® 035 Drug Coated Balloon PTA Catheter
Indications for Use: The Lutonix® 035 Drug Coated Balloon PTA catheter is indicated for percutaneous transluminal
angioplasty, after pre-dilatation, of de novo or restenotic lesions up to 150 mm in length in native superficial femoral or popliteal
arteries with reference vessel diameters of 4-6 mm.
Contraindications: The Lutonix® Catheter is contraindicated for use in: 1) Patients who cannot receive recommended antiplatelet 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 Lutonix® 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 Lutonix® Catheter have not been established for treatment in cerebral, carotid,
coronary, or renal vasculature. 8) The safety and effectiveness of using more than two Lutonix® 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 Lutonix® 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 noncontrollable 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.
Bard, Advancing Lives and the Delivery of Health Care, and Lutonix are trademarks and/or registered trademarks of C. R. Bard, Inc., or an
affiliate. All other trademarks are property of their respective owners. Copyright © 2014, C. R. Bard, Inc. All Rights Reserved.
Illustration by Mike Austin. Copyright © 2014. All Rights Reserved.
Bard Peripheral Vascular, Inc.
1625 W. 3rd Street Tempe, AZ 85281 USA www.bardpv.com
Tel: 1 480 894 9515 / 1 800 321 4254
Fax: 1 480 966 7062 / 1 800 440 5376