AngioScore - AngioSculpt PTCA
by AngioScore

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DESCRIPTION
AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Scoring Balloon Catheter

The AngioSculpt Scoring Balloon Catheter is a new tool in the treatment of simple to complex lesions, including in-stent restenosis (ISR) and type C lesions. AngioSculpt can be used in treating fibro-calcific, bifurcation and ostial lesions. When used for pre-dilatation prior to stenting, AngioSculpt has been proven to yield a 33%-50% greater luminal gain than either direct stenting or pre-dilatation with a conventional angioplasty balloon catheter.

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-MedwrenchAdmin
13 years ago
FDA Recall: AngioSculpt EX PTCA
[b]Recall Class:[/b] Class I [b]Date Recall Initiated:[/b] December 4, 2009 [b]Product:[/b] AngioSculpt "EX" Percutaneous Transluminal Coronary Angioplasty (PTCA) Scoring Balloon Catheter (all Part/REF Numbers 2034-XXYY with lot numbers less than F09060003). [b]This recall only includes "EX" Catheters.[/b] This product was distributed from January 30, 2009 through December 4, 2009. [b]Use:[/b] The AngioSculpt PTCA Scoring Balloon Catheter is used to dilate narrowed coronary arteries (stenosis), and to improve blood flow to the heart muscle (myocardial perfusion). Recalling Firm: AngioScore Inc. 5055 Brandin Court Fremont, California 94538 [b]Reason for Recall:[/b] The PTCA catheters may become separated during use in which fragments of the catheter may become lodged in coronary arteries. This may result in serious injuries, including death. Public Contact: Customers may contact AngioScore Customer Service at 1-877-264-4692. On December 4, 2009, the company sent its customers a recall notice addressed to Catheterization Laboratory Managers. The recall notice instructed the Catheterization Laboratory Managers to inspect their inventory for this recalled product from the involved lot, and separate it from their inventory. The managers were also asked to record all the affected products and to FAX the return forms to the company. AngioScore Customer Service has contacted its customers and provided instructions for the return and replacement of the affected product. Customers may contact the company at 1-877-264-4692. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. [i]Via Medical Dealer Magazine and the FDA[/i]Reply

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-MedwrenchAdmin
13 years ago
Impact of Different Pre-Dilation Strategies on Stent Expansion
Impact of Different Pre-Dilation Strategies on Stent Expansion: An Intravascular Ultrasound Study.Reply
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Impact of Different Pre-Dilation Strategies on Stent Expansion

FEATURES

[list]   [*] Flexible nitinol scoring element with three rectangular spiral struts works in tandem with a semi-compliant balloon to score the target lesion   [*] Balloon inflation focuses uniform radial forces along the edges of the nitinol element, scoring the plaque and resulting in a more precise and predictable outcome   [*] Low crossing profile (2.7F maximum), 0.014” system compatible with 6F guiding catheters   [*] Semi-compliant balloon material allows the physician to tailor the device size to the vessel (2–20 atm) depending on the size of the balloon   [*] Two radiopaque markers indicate the working ends of the scoring balloon   [*] Nitinol-enhanced balloon deflation for excellent rewrap and recross capabilities   [/list]

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FDA Recall: AngioSculpt EX PTCA

Recall Class:> Class I Date Recall Initiated:> December 4, 2009 Product:> AngioSculpt "EX" Percutaneous Transluminal Coronary Angioplasty (PTCA) Scoring Balloon Catheter (all Part/REF Numbers 2034-XXYY with lot numbers less than F09060003). This recall only includes "EX" Catheters.> This product was distributed from January 30, 2009 throu...

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