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.
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