FDA Clears Additional Sizes for TriReme's Chocolate PTA Balloon Catheter

June 19, 2012—TriReme Medical, Inc. (Pleasanton, CA) announced that it has received US Food and Drug Administration clearance for an expanded matrix of sizes for its Chocolate percutaneous transluminal angioplasty (PTA) balloon catheter for treatment of lesions in the peripheral vasculature in balloon diameters from 2 to 4 mm and in balloon lengths up to 120 mm.

“Chocolate has become an essential part of my routine practice for treating below-the-knee lesions,” commented Rajesh Dave, MD, in the company's announcement. Dr. Dave is Chief Medical Executive and Director at Cardiac Catheterization Laboratories, Holy Spirit Cardiovascular Institute in Camp Hill, Pennsylvania. He added, "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."

Chocolate's design incorporates a constraining structure over a semicompliant balloon to facilitate the formation of small modules or "pillows." Through this mechanism of action, Chocolate minimizes shear stress and allows for uniform inflation and rapid deflation, according to the company. The Chocolate "pillows" can expand locally to facilitate plaque modification and are designed to lower the strain and trauma induced on the vessel wall.