AngioSculpt XL
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Peripheral Intervention Ordering Information The AngioSculpt XL is now available in even longer lengths, 100 mm providing a greater array of sizes to meet the needs of treating diffuse disease in the lower extremities. – onger balloon length can lead to fewer inflations and reduced L procedure times – nly 100mm and 200mm devices to feature the proprietary O AngioSculpt Scoring Technology – Available in a wide range of balloon sizes Balloon Size Compliance Chart K 1. iesz RS, Scheinert D, Peeters PJ, et al. Results from the international registry of the AngioSculpt Scoring Balloon Catheter for the treatment of infra-popliteal disease. J Am Coll Cardiol. 2008;51:10 (suppl B);75. 2. Scheinert D, Peeters P, Bosiers M, et al. Results of the multicenter first-in-man study of a novel scoring balloon catheter for the treatment of infra-popliteal peripheral arterial disease. Catheter Cardiovasc Interv. 2007;70:1034-1039. 3. AngioSculpt Test Plan ST-1197 (2008), on file at AngioScore, Inc. 4. Fonseca A, Costa JR, Abizaid A, et al. Intravascular ultrasound assessment of the novel AngioSculpt Scoring Balloon Catheter for the treatment of complex coronary lesions. J Invasive Cardiol. 2008;20:21-27. CE Mark Granted for Peripheral Applications CAUTION: Federal (USA) Law restricts this device to sale by or on the order of a physician. INDICATIONS The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature. CONTRAINDICATIONS None known for percutaneous transluminal angioplasty (PTA) procedures. WARNINGS This device is intended for single (one) patient 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. The inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis, in order to reduce potential vessel damage. 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. Balloon pressure should not exceed the rated burst pressure (RBP). Refer to product label for device-specific information. The RBP is based on results of in-vitro testing. At least 99.9% of the balloons (with a 95% confidence level) will not burst at or below their RBP. Use of a pressure monitoring device is recommended to prevent over-pressurization. Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon. Proceed cautiously when using the AngioSculpt catheter in a freshly deployed bare metal or drug-eluting stent. The AngioSculpt catheter has not been tested for post-dilation of stents or in lesions distal to freshly deployed stents in clinical studies. Bench testing has shown no additional risk when inserting or withdrawing the AngioSculpt catheter through stents (no interference with stent struts, no retention of or damage to the AngioSculpt catheter). Use the catheter prior to the "Use Before" (expiration) date specified on the package. PRECAUTIONS A thorough understanding of the principles, clinical applications and risks associated with PTA is necessary before using this product. Any use for procedures other than those indicated in these instructions is not recommended. The device is not recommended for use in lesions that may require inflation pressures higher than those recommended for this catheter. Do not use if package is opened or damaged. Prior to angioplasty, the catheter should be examined to verify functionality, device integrity and to ensure that its size and length are suitable for the specific procedure for which it is to be used. During and after the procedure, appropriate anticoagulants, antiplatelet agents and vasodilators should be administered to the patient according to institutional practice for peripheral angioplasty of similar arteries. Pass the AngioSculpt catheter through the recommended introducer sheath size or minimum size guiding catheter indicated on the product label. PTA Scoring Balloon Catheter ADVERSE EFFECTS Possible adverse effects include, but are not limited to, total occlusion of the treated artery, arterial dissection or perforation, arterial spasm, pseudoaneurysm, restenosis of the dilated artery, embolism, thrombus, retained device components, hemorrhage or hematoma, arteriovenous fistula. 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 6. MASCOT Presented at Veith 2009 (New York, NY) and CRT 2010 (Washington, DC) 5. Bosiers et al, Use of the AngioSculpt Scoring Balloon for Infrapopliteal Lesions in Patients with Critical Limb Ischemia: 1-year Outcome Vascular, Vol. 17. No. 1, pp. 29-35. 2009. Summary Of Safety And Effectiveness —  PTA Catheter Nominal Pressure Rated Burst Pressure ©2015 Spectranetics. All rights reserved. Approved for external distribution. D023229-01 042015 Always Reaching Farther Always Reaching Farther

ANGIOSCULPT® XL PTA SCORING BALLOON CATHETER Big Score…in Longer Lengths Designed specifically to address long, diffuse lesions commonly found in infrainguinal arteries, the AngioSculpt XL PTA Scoring Balloon Catheter, now available in 100mm and 200mm lengths, offers 360˚ of precise and effective dilatation. AngioSculpt’s smart scoring balloon technology delivers a unique combination of controlled, effective dilatation and predictable device safety. Scoring Element SCORING MEANS RESULTS. The longer length of AngioSculpt XL provides more coverage and convenience for Smooth electropolished...