TriReme Medical announced that it 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.
Chocolate’s novel design incorporates a constraining structure over a semi-compliant balloon to facilitate the formation of small modules (“pillows”). Through this advanced mechanism of action, Chocolate minimises 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.
“Chocolate has become an essential part of my routine practice for treating below the knee lesions,” said Rajesh Dave, chief medical executive and director at Cardiac Catheterization Laboratories, Holy Spirit Cardiovascular Institute, Camp Hill, Pennsylvania, USA. “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.”