Treating complex lesions with traditional balloon

angioplasty can result in:

• Vessel dissection

• Poor luminal gain

• Lesion recoil

• Balloon slippage

• Poor stent apposition

The Excimer Laser Coronary Atherectomy (ELCA) Cath-

eter and the AngioSculpt® PTCA Scoring Balloon Catheter

can safely cross, prepare and treat a wide range of complex

lesion types, modifying plaque to provide easier stent

delivery, more predictable stent expansion and better stent

apposition, while decreasing the risk of vessel dissection.4-7

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.

In-stent restenosisThe AngioSculpt® PTCA Scoring Balloon Catheter:

• Resists slipping within the vessel

• Provides improved luminal gain

• Allows for increased focal pressure to reset stents,

reducing the need for future additional stents

The ELCA™ Coronary Laser Atherectomy Catheter:

• Modifies plaque, leading to better stent apposition

• Vaporizes lesion material

• Maximizes lumen for additional stent placement

Fibrocalcific and ostial lesionsThe AngioSculpt® PTCA Scoring Balloon Catheter:

• Applies 15 to 25 times the force of high-pressure balloons

• Modifies plaque to improve luminal gain

• Has a 2/3 lower dissection rate than standard balloons9

Chronic total occlusionsThe ELCA™ Coronary Laser Atherectomy Catheter:

• Crosses the lesion and modifies the plaque to allow for

balloon delivery and definitive treatment with drug-

eluting stents

• Treats the entire lesion

• Modifies plaque to create a lumen that allows for delivery

of other devices

Long diffuse lesionsThe ELCATM Coronary Laser Atherectomy Catheter:

• Vaporizes lesion material into particles smaller than a red

blood cell

• Increases luminal size for good stent apposition

• Prepares the vessel for precise coronary stent delivery10

A complete portfolio for complex casesThe goal of all CAD treatment is a lasting, positive outcome

for the patient. Only Spectranetics offers a complete port-

folio of solutions for optimal vessel preparation in widely

complex CAD cases. The ELCATM Coronary Laser Atherecto-

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.

AngioSculpt® Acute Gain5

Direct Stent

1.2

0.2

0.4

0.6

0.8

1.0

POBA AngioSculpt

p=0.004

Acu

te G

ain

(mm

)

• 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

ELCA™ Success Rates

Study Lesion TypeTechnical Success

Procedural Success

MACE Rates*

Bilodeau

Calcified and Complex Coronary Lesions1

92.0% 93.0%

8.0%Calcified, Uncrossable, Resistant Coronary Lesions2

95.5% 95.5%

Pratsos Crossable Coronary Lesions3

98.1% 99.0% 0.0%

Treatment Algorithm

Segment CROSS PREP TREAT

In-Stent Restenosis

Fibrocalcific Lesions

CTOs Crossable with a Wire

Ostial Lesions

Long Diffuse Lesions

AngioSculpt® Indications: Treatment of hemodynamically

significant coronary artery stenosis,

including in-stent restenosis and

complex type C lesions, for the purpose

of improving myocardial perfusion.

ELCA™ Indications:

• Total occlusions traversable by a guidewire

• Occluded SVGs

• Ostial lesions

• Moderately calcified stenoses

• Long lesions (>20 mm)

• Lesions that previously failed PTCA

• Restenosis in 316L stainless steel stents prior to brachytherapy

0.8 + 0.4

0.9 + 0.6

1.2 + 0.4

*No perforations reported

ELCA Success and Safety Rates

PREPARE TO SUCCEED: SAFE AND EFFECTIVE PLAQUE MODIFICATION FOR CAD TREATMENT

Vascular Intervention

Always Reaching Farther

Corporate HeadquartersThe Spectranetics Corporation9965 Federal Dr., Colorado Springs, CO 80921Tel: 719-447-2000 • Fax: 719-447-2022 Customer Service: 800-231-0978

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©2015 Spectranetics. All rights reserved. Approved for external distribution. D024586-01 022015

Important Safety InformationELCA & ELCA X-80 The Excimer Laser Coronary Atherectomy Catheters (ELCA) are used in conjunc-tion 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 surgi-cal 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 CATHETERThe 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.

ContraindicationsThe 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.

WarningsAdminister appropriate antiplatelet, anticoagulant and coronary vasodilator ther-apy, 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 cross- contamination. 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.

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% confi-dence) 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.

Never use air or any gaseous medium to inflate the balloon. Use the device prior to the expiration date specified on the package.

PrecautionsTake 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 angioplas-ty, 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 An-gioSculpt catheter has advanced beyond the end of the guidewire, withdraw the catheter and reload the wire before advancing again.

Possible adverse effectsDeath; Heart Attack (acute myocardial infarction); Total occlusion of the treated cor-onary 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; Pseudo-aneurysm; 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 (hyper-tension) 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.

References1 Bilodeau, Luc MD, et al. Novel Use of a High-Energy Excimer Laser Catheter for

Calcified and Complex Coronary Artery Lesions. Catheterization and Cardio-vascular Interventions (62:155-161, 2004).

2 Wacinski P, Bilodeau L, Crepeau J, Gallo R, Ibrahim R, Tanguay J-F, Doucet S. Abstract presented at TCT (2004).

3 Pratsos et al. Abstract 10-A-103-CRT presented at CRT 2010.4 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.

5 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.

6 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.

7 Topaz, On, et al, 2001. Optimal Spaced Excimer Laser Coronary Catheters Per-formance Analysis, Journal of Clinical Laser Medicine and Surgery, Vol 19, Issue 1, 9-14.

8 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.

9 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.

10 Stone et al. (2005) Circulation; 112:2364-2372.

PREPARE TO SUCCEED with definitive therapy by safely and effectively modifying plaque for easier stent delivery, more predictable stent expansion and better stent apposition.