FDA Clears TriReme's Chocolate PTA Balloon Catheter

December 21, 2011—TriReme Medical, Inc. (Pleasanton, CA) announced that it has received 510(k) clearance from the US Food and Drug Administration to market its Chocolate percutaneous transluminal angioplasty (PTA) balloon catheter for the treatment of occluded peripheral arteries. The Chocolate catheter was developed in collaboration with TriReme's subsidiary, Quattro Vascular Pte Ltd (Singapore). In January 2011, the device received CE Mark approval for marketing in Europe.

According to TriReme, the device incorporates a constraining structure over a semi-compliant balloon to facilitate the formation of small modules or “pillows.” With this mechanism, Chocolate minimizes shear stress and allows for uniform inflation and rapid deflation. The Chocolate pillows can expand locally to facilitate plaque modification and are designed to lower the strain and trauma induced on the vessel wall. The Chocolate balloon catheter will be used to treat peripheral vascular disease, both above and below the knee, the company stated.

"I am very excited to be the first physician to use Chocolate PTA in the United States," commented Jihad Mustapha, MD. "We treated complex occlusions with outstanding results, no elastic recoil, and no dissections, which are the most feared complications in patients with critical limb ischemia. This product will be a crucial tool in the battle against critical limb ischemia and major amputations."