FDA clears TriReme’s Chocolate PTA balloon catheter


On 21 December, TriReme 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 (“Chocolate”) for the treatment of occluded peripheral arteries. Chocolate was developed in collaboration with TriReme’s subsidiary Quattro Vascular in Singapore. 

Chocolate features a constraining structure over a semi-compliant balloon to facilitate the formation of small modules (“pillows”). Through this advance 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.

“I am very excited to be the first physician to use Chocolate PTA in the USA,” said Jihad Mustapha, director of Endovascular Interventions and Research at Metro Health Hospital in Wyoming, Michigan, USA. “We treated complex occlusions with outstanding results, no elastic recoil and no dissections which are the most feared complications in patients with critical limb ischaemia. This product will be a crucial tool in the battle against critical limb ischaemia and major amputations.”

“We are pleased to receive US regulatory approval for Chocolate PTA,” added Eitan Konstantino, president and CEO of TriReme. “Chocolate is a great addition to our line of proprietary peripheral PTA catheters already available in the USA, Europe and Asia. We are thrilled with Dr Mustapha’s initial US experience and believe that Chocolate will provide substantial clinical benefits to patients suffering from peripheral vascular disease, both above and below the knee.”

Chocolate was CE marked in January 2011.