AngioSculpt PTA Scoring Balloon Catheter. 26. AngioSculpt RX PTCA scoring balloon catheter significantly alters the landscape for treating CAD, offering the advanced performance that only an innovative clinical solution can provide. J Invasive Cardiol. It is not, however, fully elucidated whether AngioSculpt for advanced vascular access stenosis, difficult to expand by conventional balloons, successfully provides bailout angioplasty. 92, Issue 6, Supplement 1: 166L. A nitinol scoring element-equipped helical balloon catheter (AngioSculpt®) has been altered the landscape for treating several vascular diseases. Designed specifically to address complex lesions found in infrainguinal arteries, the AngioSculpt PTA scoring balloon catheter offers 360˚ of precise and effective dilatation. Intravascular ultrasound assessment of the novel AngioSculpt Scoring Balloon Catheter for the treatment of complex coronary lesions. J Invasive Cardiol. "In spite of advances in medical device technology, maintaining hemodialysis access function … This device is composed of two major components, a minimally compliant balloon and three nitinol wore. The AngioSculpt PTCA scoring balloon catheter is an essential tool in the treatment of a wide range of coronary lesions, including in-stent restenosis (ISR) and type C lesions. Calcified thrombus is rarely observed in a coronary artery embolism, especially one formed … Primary DI Number: 00813132021238. The AngioSculpt device measures approximately 137 cm in length and is available in diameters from 2 to 3.5 mm in increases of 0.5 mm. The AngioSculpt catheter should not be used for coronary artery lesions “The AngioSculpt Scoring Balloon Catheter represents a significant advance in the treatment of challenging coronary and peripheral lesions. This device is designed to make a ‘scoring … 2008; 20: 21-27; 2 Mooney M, Teirstein P, Moses J, et al. Not for use in the coronary or The AngioSculpt Scoring Balloon Catheter represents the next generation in angioplasty catheters. Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring. AngioSculpt Test Plan ST-1197 (2008), on file at AngioScore, Inc. 4. The AngioSculpt PTA Scoring Balloon Catheter in 7 and 8 mm diameter assists physicians with a difficult patient set, targeting lesions in the hemodialysis access that are resistant to standard balloon angioplasty. AngioSculpt Test Plan ST-1197 (2008), on file at AngioScore, Inc. 4. Intravascular ultrasound assessment of the novel AngioSculpt Scoring Balloon Catheter for the treatment of complex coronary lesions. The AngioSculpt Scoring Balloon Catheter (AngioScore, Inc., Fremont, CA) is composed of a semicompliant balloon encircled by three nitinol spiral struts providing targeted lesion scoring on balloon inflation. Catheter Cardiovasc Interv. Not for use in the coronary or A nitinol scoring element-equipped helical balloon catheter (AngioSculpt®) has been altered the landscape for treating several vascular diseases. 3. Fonseca A, Costa JR, Abizaid A, et al. Fonseca A, Costa JR, Abizaid A, et al. J Invasive Cardiol. Source: AngioScore, Inc. Brief Summary: The purpose of this study is to evaluate a new angioplasty catheter, AngioSculpt® for the treatment of bifurcation lesions (blockages occurring at branch points) in … Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. 1 MB. Company Name: Spectranetics Corporation. 2008;20:21-27. The AngioSculpt PTA Scoring Balloon Catheter in 7 and 8 mm diameter assists physicians with a difficult patient set, targeting lesions in the hemodialysis access that are resistant to standard balloon angioplasty. 2007;70:1034-1039. In June 2014, Spectranetics acquired AngioScore, developer of the AngioSculpt balloon catheter. Designed to address a wide range of peripheral lesions— including the long, diffuse lesions commonly found in … The AngioSculpt Scoring Balloon Catheter represents the next generation in angioplasty catheters. GEOALIGN ® Markers are not a replacement for fluoroscopy. The AngioSculpt (AngioScore Inc., Fremont, CA, USA) was developed as a coronary interventional device, which consists of a semi-compliant balloon surrounded by spiral nitinol element that works in tandem with the balloon in order to ‘score’ the target lesion upon balloon inflation 1, 2 . The product assists physicians with a difficult patient set, targeting lesions in the hemodialysis access that are resistant to … Designed specifically to address long, diffuse lesions commonly found in infrainguinal arteries, 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. The recall affects 17,682 AngioSculpt PTA scoring balloon catheters (OTW 0.018" Platform) of multiple sizes, including all sizes and lot codes for … 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. The AngioSculpt PTA scoring balloon catheter in 7 and 8 millimeter diameter balloon sizes are ideally suited to treat the narrowing of the native or synthetic fistula. 3. The AngioSculpt Scoring Balloon Catheter is comprised of a semi-compliant angioplasty balloon surrounded by a nitinol scoring element. The idea is to provide controlled predictable scoring of the artery wall to allow better dilatation with the semi compliant balloon. … The AngioSculpt Scoring Balloon Catheter is an essential tool for the treatment of both coronary and peripheral artery disease. The AngioSculpt RX PTCA scoring balloon catheter is the only specialty scoring device indicated for … Company Name: Spectranetics Corporation. Based on the innovative AngioSculpt platform, the balloon catheter is coated with a specialised formula that includes the antiproliferative drug Paclitaxel. Commercial Distribution Status: In Commercial Distribution. The AngioSculpt catheters provide the versatility and effectiveness of a new technology together with the simplicity and deliverability of traditional high-performance balloon catheters. The AngioSculpt balloon catheter was developed by AngioScore, Inc., which was acquired June 30, 2014, by The Spectranetics Corporation. AngioSculpt delivers a unique combination of controlled, effective dilatation and predictable device safety. Catalog Number: 2001-2010. The AngioSculpt® Scoring Balloon Catheter is a standard PTCA catheter with a scoring balloon near the distal tip. 2007;70:1034-1039. Device Identifier (DI) Information. Product. 2008; 20: 21-27; 2. Improved technical experience coupled with a vast array of technologies to choose from has allowed the J Invasive Cardiol. The AngioSculpt™ scoring balloon catheter (AngioScore, Inc., Fremont, California) has recently been developed for percutaneous intervention in coronary and peripheral arteries.
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