TriReme Medical Inc. Receives FDA 510(K) Clearance for Chocolate PTA Balloon Catheter
"I am very excited to be the first physician to use Chocolate PTA in the US," said Dr. Jihad Mustapha, Director of Endovascular Interventions and Research at Metro Health Hospital in Wyoming, Michigan. "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."
"We are pleased to receive US regulatory approval for Chocolate PTA," added Eitan Konstantino, PhD, President and CEO of TriReme. "Chocolate is a great addition to our line of proprietary peripheral PTA catheters already available in the US, 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."
About TriReme Medical, Inc.
Based in Pleasanton, California, TriReme Medical, Inc. is a privately held medical device company dedicated to the development, manufacturing, and commercialization of next generation percutaneous devices for the treatment of complex coronary and peripheral arterial disease. The Company's novel interventional therapies are specifically designed for large, unmet clinical needs.
SOURCE TriReme Medical, Inc.