FDA Clears Trireme's Chocolate PTCA Balloon Catheter

June 5, 2014—QT Vascular Ltd. announced that its wholly owned United States subsidiary, TriReme Medical LLC, received US Food and Drug Administration (FDA) 510(k) clearance to market the Chocolate percutaneous transluminal coronary angioplasty (PTCA) balloon catheter in the United States. The Chocolate PTCA device is indicated for balloon dilatation of the stenotic portion of the coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

In the company’s press release, Martin Leon, MD, of the Columbia University Center for Interventional Vascular Therapy, commented, “Chocolate PTCA is an exciting new product for interventional cardiologists. It leverages the strong clinical outcomes and low rates of dissections of the Chocolate PTA balloon catheter while providing an important new tool that could be now used in coronary arteries."

According to the company, the Chocolate PTA device—used for the treatment of patients with peripheral arterial disease—gained European CE Mark approval in January 2011 and FDA clearance for use in the peripheral vasculature in December 2011. The company advised that the Chocolate PTA device demonstrated low rates of dissections and bailout stenting in clinical data presented early this year by Tony Das, MD, at LINC 2014: the Leipzig Interventional Course in Leipzig, Germany.

The Chocolate PTCA device was designed with similar engineering principles and is aimed to provide predictable and uniform dilatation of the coronary vasculature. There are no clinical data available for the Chocolate PTCA device at this point in time, noted the company.