Download thorough vessel preparation: treating complex lesions

THOROUGH VESSEL PREPARATION: TREATING COMPLEX LESIONS
Complex CAD cases with complex lesions create tough challenges—and require
the right tools to help successfully cross, prep and treat them. Spectranetics offers a
complete portfolio of solutions to help manage complex CAD cases.
Treating complex lesions with traditional balloon
In-stent restenosis
Fibrocalcific and ostial lesions
Long diffuse lesions
angioplasty can result in:
The AngioSculpt PTCA Scoring Balloon Catheter:
The AngioSculpt PTCA Scoring Balloon Catheter:
The ELCATM Coronary Laser Atherectomy Catheter:
• Vessel dissection
• Resists slipping within the vessel
• Applies 15 to 25 times the force of high-pressure balloons
• Vaporizes lesion material into particles smaller than a red
• Poor luminal gain
• Provides improved luminal gain
• Modifies plaque to improve luminal gain
• Lesion recoil
• Allows for increased focal pressure to reset stents,
• Has a 2/3 lower dissection rate than standard balloons9
®
®
blood cell
reducing the need for future additional stents
• Balloon slippage
• Poor stent apposition
The ELCA™ Coronary Laser Atherectomy Catheter:
The Excimer Laser Coronary Atherectomy (ELCA) Cath-
• Modifies plaque, leading to better stent apposition
eter and the AngioSculpt® PTCA Scoring Balloon Catheter
• Vaporizes lesion material
can safely cross, prepare and treat a wide range of complex
• Maximizes lumen for additional stent placement
lesion types, modifying plaque to provide easier stent
• Prepares the vessel for precise coronary stent delivery10
Chronic total occlusions
The ELCA™ Coronary Laser Atherectomy Catheter:
A complete portfolio for complex cases
• Crosses the lesion and modifies the plaque to allow for
The goal of all CAD treatment is a lasting, positive outcome
balloon delivery and definitive treatment with drug-
for the patient. Only Spectranetics offers a complete port-
eluting stents
folio of solutions for optimal vessel preparation in widely
complex CAD cases. The ELCATM Coronary Laser Atherecto-
• Treats the entire lesion
delivery, more predictable stent expansion and better stent
• Modifies plaque to create a lumen that allows for delivery
apposition, while decreasing the risk of vessel dissection.
4-7
• Increases luminal size for good stent apposition
of other devices
my Catheter and the AngioSculpt® PTCA Scoring Balloon
Catheter modify plaque, providing easier stent delivery,
more predictable stent expansion, increased luminal gain
and better stent apposition.
Treatment Algorithm
ELCA™ Success Rates
AngioSculpt® Acute Gain5
CROSS
PREP
TREAT
Technical
Success
Procedural
Success
Calcified and
Complex
Coronary Lesions1
92.0%
93.0%
95.5%
CTOs Crossable with a Wire
Calcified,
Uncrossable,
Resistant
Coronary Lesions2
Ostial Lesions
Crossable
Coronary Lesions3
In-Stent Restenosis
Study
Fibrocalcific Lesions
Bilodeau
Long Diffuse Lesions
Pratsos
Lesion Type
98.1%
95.5%
99.0%
MACE
Rates*
8.0%
0.9 + 0.6
1.0
Acute Gain (mm)
Segment
1.2 + 0.4
1.2
ELCA Success and Safety Rates
0.8
0.8 + 0.4
p=0.004
*No perforations reported
Treatment of hemodynamically
• Occluded SVGs
including in-stent restenosis and
• Ostial lesions
complex type C lesions, for the purpose
• Moderately calcified stenoses
of improving myocardial perfusion.
• Restenosis in 316L stainless steel
stents prior to brachytherapy
Direct Stent
•
• Total occlusions traversable by
a guidewire
• Lesions that previously failed PTCA
0.2
•
AngioSculpt® Indications:
• Long lesions (>20 mm)
0.6
0.4
0.0%
ELCA™ Indications:
POBA
AngioSculpt
p=0.004 applies to the comparison between Direct Stent vs.
AngioSculpt
Comparison between Direct Stent vs. Pre-dil with POBA shows
no statistical difference
significant coronary artery stenosis,
Important Safety Information
ELCA & ELCA X-80
The Excimer Laser Coronary Atherectomy Catheters (ELCA) are used in conjunction with the Spectranetics CVX-300® Excimer Laser System and are intended for
use in patients with a variety of blockages in single or multivessel coronary artery
disease. ELCA is usually used in conjunction with other therapies, such as balloon
angioplasty or stenting. The use of ELCA may be unsafe in some patients or in
treating certain types of blockages. The ELCA X-80 catheter should not be used
in patients with weakened heart muscles (ejection fraction <30%) or in cases of
acute heart attacks. Rarely a patient undergoing ELCA may require urgent surgical treatment for a complication; therefore, patients who are not candidates for
coronary bypass graft surgery should not undergo treatment with ELCA. Ask your
doctor if you are a candidate for ELCA.
Potential adverse events associated with procedures used to treat coronary artery
disease may include: a tear, rupture, damage to the artery; a sudden, temporary or
ongoing reclosure of the treated artery; blood clot or obstruction of the artery by
plaque debris. Other complications may occur.
Rare but serious potential adverse events include: the need for urgent additional
procedures or surgery due to bleeding, vascular damage, loss of blood flow or
other complications; and irregular heartbeat, heart attack or death.
This information is not intended to replace a discussion with your health care
provider on the benefits and risks of this procedure to you.
ANGIOSCULPT PTCA CATHETER
The AngioSculpt Scoring Balloon Catheter is indicated for use in the treatment
of hemodynamically significant coronary artery stenosis, including in-stent
restenosis and complex type C lesions, for the purpose of improving myocardial
perfusion.
Contraindications
The AngioSculpt catheter should not be used for the following: coronary artery
lesions unsuitable for treatment by percutaneous revascularization: coronary
artery spasm in the absence of a significant stenosis.
Warnings
Administer appropriate antiplatelet, anticoagulant and coronary vasodilator therapy, consistent with institutional practice for coronary stent procedures, during
and after the procedure. This device is intended for single (one) use only.
Do not resterilize and/or reuse, as this can potentially result in compromised
device performance and increased risk of inappropriate resterilization and crosscontamination. For use in de novo or in-stent restenosis (ISR) lesions, the inflated
diameter size of the balloon should approximate the vessel diameter size just
proximal and distal to the stenosis, in order to reduce potential vessel damage.
When used to pre-dilate the lesion prior to pre-planned stenting, the catheter
should be one size smaller than the estimated vessel diameter (e.g., a 2.5 mm
diameter device should be used in a vessel estimated to have a 3.0 mm diameter).
PTCA in patients who are not acceptable candidates for coronary artery bypass
graft surgery requires careful consideration, including possible hemodynamic
support during PTCA, as treatment of this patient population carries special risk.
PREPARE
TO SUCCEED
with definitive therapy by safely and effectively
modifying plaque for easier stent delivery,
more predictable stent expansion and better
stent apposition.
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 under vacuum. If resistance is met
during manipulation, determine the cause of the resistance before proceeding.
Do not exceed the rated burst pressure (RBP) during balloon inflation. The RBP is
based on results of in-vitro testing. At least 99.9% of the balloons (with 95% confidence) will not burst at or below their RBP. Use of a pressure monitoring device is
recommended to prevent over-pressurization. PTCA should only be performed at
hospitals where emergency coronary artery bypass graft surgery can be quickly
performed in the event of a potential cardiovascular injury or life-threatening
complication. Use only the recommended balloon inflation medium.
Vascular Intervention
Never use air or any gaseous medium to inflate the balloon. Use the device prior
to the expiration date specified on the package.
PREPARE TO SUCCEED:
SAFE AND EFFECTIVE
PLAQUE MODIFICATION
FOR CAD TREATMENT
Precautions
Take extra care when using the AngioSculpt catheter to treat a lesion distal to a
freshly deployed stent. This precaution is particularly applicable to a drug-eluting
stent so as to minimize the risk of damage to the stent coating. Prior to angioplasty, examine the catheter to verify functionality, catheter integrity and to ensure
that its size and length are suitable for the specific procedure for which it is to be
used. Only physicians trained in the performance of percutaneous transluminal
coronary angioplasty should use the AngioSculpt catheter. Do not rotate the
catheter shaft in excess of 180 degrees when the tip is constrained.
Do not rotate the catheter luer hub in excess of five (5) turns during use. Do
not advance or retract the AngioSculpt catheter over the floppy portion of the
guidewire. Catheter manipulation, including advancement and retraction, should
be performed by grasping the catheter shaft. If unusual resistance is felt when the
catheter is being manipulated or if it is suspected that the guidewire has become
kinked, carefully remove the entire catheter system (AngioSculpt catheter and
steerable guide wire) as a unit. If fluoroscopic guidance indicates that the AngioSculpt catheter has advanced beyond the end of the guidewire, withdraw the
catheter and reload the wire before advancing again.
Possible adverse effects
Death; Heart Attack (acute myocardial infarction); Total occlusion of the treated coronary artery; Coronary artery dissection, perforation, rupture, or injury; Pericardial
tamponade; No/slow reflow of treated vessel; Emergency coronary artery bypass
(CABG); Emergency percutaneous coronary intervention; CVA/stroke; Pseudoaneurysm; Restenosis of the dilated vessel; Unstable angina; Thromboembolism
or retained device components; Irregular heart rhythm (arrhythmias, including
life-threatening ventricular arrhythmias); Severe low (hypotension)/high (hypertension) blood pressure; Coronary artery spasm; Hemorrhage or hematoma; Need
for blood transfusion; Surgical repair of vascular access site; Creation of a pathway
for blood flow between the artery and the vein in the groin (arteriovenous fistula);
Drug reactions, allergic reactions to x-ray dye (contrast medium); Infection.
References
Bilodeau, Luc MD, et al. Novel Use of a High-Energy Excimer Laser Catheter for
Calcified and Complex Coronary Artery Lesions. Catheterization and Cardiovascular Interventions (62:155-161, 2004).
1
Wacinski P, Bilodeau L, Crepeau J, Gallo R, Ibrahim R, Tanguay J-F, Doucet S.
Abstract presented at TCT (2004).
2
3
Pratsos et al. Abstract 10-A-103-CRT presented at CRT 2010.
Mooney M, Teirstein P, Moses J, et al. Final results from the US multi-center
trial of the AngioSculpt Scoring Balloon Catheter for the treatment of complex
coronary artery lesions. Am J Cardiol 2006;98(8 suppl):121M.
4
Costa JR, Mintz GS, Carlier SG, et al. Nonrandomized comparison of coronary
stenting under intravascular ultrasound guidance of direct stenting without
predilation versus conventional predilation with a semi-compliant balloon
versus predilation with a new scoring balloon. Am J Cardiol. 2007;100:812-817.
5
Sonoda S, Morino Y, Ako J, et al. Impact of final stent dimensions on long-term
results following sirolimus-eluting stent implantation: serial intravascular
ultrasound analysis from the SIRIUS trial. J Am Coll Cardio. 2004;43:1959-1963.
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Corporate Headquarters
The Spectranetics Corporation
9965 Federal Dr., Colorado Springs, CO 80921
Tel: 719-447-2000 • Fax: 719-447-2022
Customer Service: 800-231-0978
German Office
Spectranetics Deutschland GmbH
Schweinfurter Str. 7
97080 Würzburg, Germany
Phone: +49 931/4520080 • Fax: +49 931/45200811
Spectranetics International B.V.
Plesmanstraat 6, 3833 LA Leusden
The Netherlands
Tel: +31 33 4347 050 • Fax: +31 33 4347 051
Topaz, On, et al, 2001. Optimal Spaced Excimer Laser Coronary Catheters Performance Analysis, Journal of Clinical Laser Medicine and Surgery, Vol 19, Issue
1, 9-14.
7
Dahm, Johannes B MD and Kuon, Eberhard, MD. High Energy Eccentric Eximer
Laser Angioplasty for Debulking Diffuse In-Stent Restenosis Leads to Better
Acute- and 6-Month Follow-up Results. The Journal of Invasive Cardiology, Vol.
12, No. 7, July 2000.
8
Costa JR, Mintz GS, Carlier SG, et al. Nonrandomized comparison of coronary
stenting under intravascular ultrasound guidance of direct stenting without
predilation versus conventional predilation with a semi-compliant balloon
versus predilation with a new scoring balloon. Am J Cardiol. 2007;100:812-817.
9
Stone et al. (2005) Circulation; 112:2364-2372.
10
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