*mymedicalexpo

AngioSculpt

Product catalog summary

Overview: The document provides an overview of the AngioSculpt® Scoring Balloon Catheter by AngioScore, Inc., emphasizing its effectiveness in treating peripheral artery disease. It highlights data from multiple studies and publications, focusing on the device's safety and efficacy.

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

Clinical Studies and Outcomes: The document references 9 studies and 37 publications, involving 1,075 patients and 1,362 lesions across 53 multi-national sites. Key outcomes include an 86.3% 1-year limb salvage rate in critical limb ischemia (CLI) patients and a dissection rate of less than 10%.

Performance and Design: AngioSculpt is noted for minimal balloon slippage and effective dilatation of calcified lesions. It has been used successfully as a stand-alone treatment in 58%-89.3% of cases in various studies.

Safety and Effectiveness: The device has a CE mark for peripheral applications and is restricted to sale by or on the order of a physician. It is intended for single patient use only to prevent cross-contamination and ensure device performance.

Warnings: The document advises against reusing or resterilizing the device, as this could compromise performance and increase contamination risks. Proper sizing and fluoroscopic observation are recommended during procedures.

Conclusion: AngioSculpt is presented as a reliable tool for plaque modification in peripheral arteries, backed by extensive clinical research and peer-reviewed publications.

Specifications and Usage Instructions: The document provides detailed instructions for the use of the AngioSculpt catheter. It emphasizes the importance of not exceeding the rated burst pressure (RBP) of the balloon, which is determined through in-vitro testing. A pressure monitoring device is recommended to avoid over-pressurization, and only the recommended inflation medium should be used. The catheter should be used cautiously with freshly deployed stents, as it has not been tested for post-dilation in clinical studies. The device should be used before the expiration date indicated on the package.

Precautions: Users must have a thorough understanding of the principles and risks associated with percutaneous transluminal angioplasty (PTA) before using the device. The catheter should not be used in lesions requiring higher inflation pressures than recommended. It is crucial to verify the catheter's functionality and integrity before use. Appropriate anticoagulants and other medications should be administered during and after the procedure.

Adverse Effects: Potential adverse effects include total occlusion of the treated artery, arterial dissection or perforation, arterial spasm, pseudoaneurysm, restenosis, embolism, thrombus, retained device components, hemorrhage, hematoma, and arteriovenous fistula.

Contact Information: AngioScore, Inc. is located at 5055 Brandin Court, Fremont, CA 94538. They can be contacted via phone at 510.933.7900 or toll-free at 877.264.4692. More information is available on their website, www.angioscore.com.

Legal and Patent Information: The device is restricted to sale by or on the order of a physician, as per Federal Law (USA). It is protected under US Patent No. 7022104, with other patents pending.

Catalog excerpts

Scoring Balloon Catheter

Open the catalog to page 1

Let’s clear a few things up.

Open the catalog to page 2

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...

Open the catalog to page 3

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...

Open the catalog to page 4

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...

Open the catalog to page 5

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. ©2014 Spectranetics. All Rights Reserved. Approved for External Distribution D023273-00 072014 US Patent No. 7022104 granted and other patents pending. © 2013 AngioScore, Inc. All Rights Reserved.

Open the catalog to page 6

AngioSculpt

AngioSculpt

Catalog excerpts

All Spectranetics catalogs and technical brochures

Archived catalogs