AngioSculpt
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Ordering information AngioSculpt is available in the following sizes: Model number Guidewire Sheath compatibility size (F) Summary of safety and effectiveness —  PTA catheter Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 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. None known for percutaneous transluminal angioplasty (PTA) procedures. Compliance chart Balloon size 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. 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. References 1. Kiesz RS, Scheinert D, Peeters PJ, et al. Results from the international registry of the AngioSculpt Scoring Balloon Catheter for the treatment of infrapopliteal 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 Philips. 4. 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. 5. MASCOT Presented at Veith 2009 (NYC, NY) and CRT 2010 (Washington, DC) Possible adverse effects include, but are not limited to: vessel injury such as: dissection, perforation, rupture, spasm, or arteriovenous fistula; infection/sepsis; drug reactions; allergic reactions to contrast medium; restenosis/occlusion of the dilated artery; embolism; thrombus; hypertension/hypotension; hemorrhage; hematoma; pseudoaneurysm; need for blood transfusion; surgical repair of vascular access site; no or slow reflow of the treated vessel. Adverse effects Nominal pressure Rated burst pressure PTA scoring balloon catheter ©2020 Koninklijke Philips N.V. All rights reserved. Approved for external distribution. D023229-04 122020 Philips 3721 Valley Centre Drive, Suite 500 San Diego, CA 92130 USA www.philips.com/IGTdevices Scoring means

Maximize gain. Minimize risk. The AngioSculpt PTA scoring balloon catheter 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. Advanced technology. Proven benefits. Scoring means results. See the unique advantages of AngioSculpt scoring technology. Precision Circumferential scoring across the entire length AngioSculpt features a nitinol scoring element arranged in a helical configuration, leading to uniform scoring and a procedure that is safe,...

Maximize gain. Minimize risk. The AngioSculpt PTA scoring balloon catheter 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. Advanced technology. Proven benefits. Scoring means results. See the unique advantages of AngioSculpt scoring technology. Precision Circumferential scoring across the entire length AngioSculpt features a nitinol scoring element arranged in a helical configuration, leading to uniform scoring and a procedure that is safe,...