FDA clears of Chocolate PTCA balloon catheter

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QT Vascular has announced that its wholly owned US subsidiary, TriReme Medical LLC, received United States Food and Drug Administration (FDA) 510(K) clearance to market the Chocolate percutaneous transluminal coronary angioplasty balloon catheter (Chocolate PTCA) in the United States, for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

“Chocolate PTCA is an exciting new product for interventional cardiologists,” says Martin Leon of Columbia University Center for Interventional Vascular Therapy. “It leverages the strong clinical outcomes and low rates of dissections of the Chocolate percutaneous transluminal angioplasty balloon catheter (Chocolate PTA) while providing an important new tool that could be now used in coronary arteries.”

 


Currently, the Chocolate PTA is used for the treatment of patients with vascular disease in their legs, known as peripheral arterial disease. The Chocolate PTA has demonstrated low rates of dissections and bail-out stenting in clinical studies. The Chocolate PTCA was designed with similar engineering principles and is aimed to provide predictable and uniform dilatation of the coronary vasculature. There is no clinical data available for the Chocolate PTCA at this point in time.