Peripheral Clinical Brochure

Product catalog summary

Overview: AngioScore, Inc. develops the AngioSculpt Scoring Balloon Catheter, designed for treating complex coronary and peripheral artery lesions. The document details the device's specifications, clinical studies, and safety guidelines.

Specifications: The AngioSculpt PTA Scoring Balloon Catheter is intended for dilating lesions in arteries such as iliac, femoral, and renal, but not for coronary or neuro-vasculature use.

Clinical Studies: The document references multiple studies demonstrating the device's effectiveness in treating peripheral artery disease, including multi-center trials showing positive outcomes in complex coronary lesions and infra-popliteal disease.

Safety and Effectiveness: The device has CE Mark approval for peripheral applications and is for single-use only. It should be used under high-quality fluoroscopic observation, adhering to recommended balloon inflation pressures.

Precautions and Warnings: Users should understand PTA principles and risks. The device should not be used in lesions requiring higher inflation pressures than recommended. Proper anticoagulant and antiplatelet administration is advised during and after procedures.

Adverse Effects: Potential adverse effects include arterial occlusion, dissection, perforation, spasm, pseudoaneurysm, restenosis, embolism, thrombus, and hemorrhage.

Conclusion: AngioSculpt is a leader in balloon-based plaque modification, supported by clinical trials. It optimizes plaque modification for effective stent deployment and long-term outcomes.

Effectiveness and Safety Profile: The AngioSculpt® scoring balloon catheter is effective in treating peripheral arterial disease and critical limb ischemia (CLI), with an 86.3% 1-year limb salvage rate in CLI patients and a dissection rate of less than 10%.

Performance: The device shows minimal balloon slippage, enhancing performance across various peripheral arteries, especially on calcified or fibrotic lesions.

Clinical Studies and Results: Studies confirm AngioSculpt®'s efficacy as a stand-alone treatment in 58%-89.3% of cases, with consistent performance and no significant slippage reported.

Key References: The document cites studies from journals like 'Vascular', 'Catheterization and Cardiovascular Interventions', and 'Cardiovascular Revascularization Medicine', supporting AngioSculpt®'s effectiveness and safety.

Conclusion: AngioSculpt® is a reliable and effective tool for treating peripheral arterial disease, with a strong safety profile and proven clinical results.

Catalog excerpts

Contact your AngioScore® sales representative to find out more about our peer-reviewed publications. AngioScore, Inc. 5055 Brandin Court, Fremont, CA 94538 www.angioscore.com Tel: 510.933.7900 Fax: 510.933.7901 Toll Free: 877.264.4692 [email protected] CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. ML-1121-0001 Rev A 01/14 US Patent No. 7022104 granted and other patents pending. © 2013 AngioScore, Inc. All Rights Reserved.

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Scoring Balloon Catheter

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AngioSculpt® Peer-Reviewed Publications ABSTRACTS 1. Gershony G, Virmani R, Lotan C, Konstantino E, Leon MB. A Novel Angioplasty Catheter For The Treatment Of Complex CAD: AngioSculpt®. American Journal of Cardiology September 2003; Vol. 92, Issue 6, Supplement 1: 166L. 2. Abizaid A, Feres F, Gershony G, Konstantino E, Staico R, Mattos L, Vaz V, Ferreira E, Silva CE, Sousa E. Results of the First in Man Study of the AngioSculpt Scoring Balloon Catheter. Catheterization and Cardiovascular Interventions May 2004; Vol. 62, Issue 1:117. 3. Abizaid, A, Grube E, Gershony G, Feres F, Mueller R, Staico...

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Let’s clear a few things up.

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Multiple studies have shown that AngioSculpt is a tool that delivers excellent outcomes for treating peripheral artery disease. ® Studies Published in Leading Journals. Catheterization and Cardiovascular Interventions Cardiovascular Revascularization Medicine Circulation Endovascular Forum Vascular Heart and Vessel “Plaque modification is a very important step to ensure that our destination therapies, i.e., stents, are optimally deployed so that our patients have the best long term results. AngioScore is the leader in balloon-based plaque modification, with well designed trials backing up their...

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AngioSculpt® works. 86.3% 1-Year Limb Salvage Rate in CLI Patients. <10% Dissection Rate. Bosiers M, Deloose K et al. Use of the AngioSculpt scoring balloon for infrapopliteal lesions in patients with critical limb ischemia: 1-year outcome. Vascular. 2009;17:29-35. Stand-Alone Treatment. AngioSculpt was successfully used as a stand-alone treatment in 58%-89.3% of cases in four separate studies. Kiesz RS, Scheinert D, Peeters PJ, Bosiers M, O’Sullivan G, Sultan S, Turco MA, Gray WA, Laird JR, Malik A, Mewissen MW, Dave R, Das TS, Piemonte TC, Khanna P, Gershony G. Results From the International...

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Peripheral Clinical Brochure

Peripheral Clinical Brochure

Catalog excerpts

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