TriReme balloon catheter gets FDA approval

Singapore: Asia focused medtech company TriReme Medical has received FDA clearance for an expanded matrix of sizes for its Chocolate PTA balloon catheter. Chocolate is now approved 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.

"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. "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."

"Chocolate has become an essential part of my routine practice for treating below the knee lesions," said Dr. Rajesh Dave, Chief Medical Executive and Director at Cardiac Catheterization Laboratories, Holy Spirit Cardiovascular Institute, Camp Hill, PA. "With the approval of these new sizes, I will be able to expand my use of Chocolate and begin to treat patients with disease in the popliteal artery where we usually prefer not to stent."