TriReme Medical Receives FDA Clearance for Expanded Sizes of Balloon Catheter

TriReme Medical has announced it has received FDA clearance for an expanded matrix of sizes for its Chocolate PTA balloon catheter, according to a news release.

 

Chocolate is now approved by FDA for the percutaneous transluminal treatment of lesions in the peripheral vasculature in balloon diameters from 2.0 - 4.0mm and in balloon lengths up to 120mm.

 

Chocolate's design incorporates a constraining structure over a semi-compliant balloon to facilitate the formation of small modules.

 

"This latest regulatory approval broadening the available size matrix of the Chocolate PTA balloon marks yet another important milestone for TriReme Medical," said Eitan Konstantino, president and CEO of TriReme Medical, in the release. "There is more to come; our goal is to provide a broad range of innovative tools to improve outcomes in patients suffering from complex vascular disease."

 

TriReme Medical received FDA 510(k) clearance to market Chocolate for the treatment of occluded peripheral arteries in December 2011.

 

TriReme Medical's U.S. headquarters is in Pleasanton, Calif.

 

Related Articles on FDA Clearances:

LensAR Receives FDA 510(k) Clearance for Cataract Surgery Laser System

KFx Medical Receives FDA 510(k) Clearance for Tissue Fixation Anchor

Kinetic Concepts Receives FDA 510(k) Clearance for Wound Therapy System

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Webinars

Featured Whitepapers