Chocolate Touch Drug-Coated Angioplasty Balloon Earns FDA Nod

Genesis MedTech Group has earned U.S. Food and Drug Administration (FDA) approval for its Chocolate Touch drug-coated balloon (DCB) PTA catheter, developed by TriReme Medical, to treat peripheral artery disease in the superficial femoral artery and popliteal artery.
 
Chocolate Touch was shown to have “statically superior patency and non-inferior safety” at 12 months compared to the Lutonix DCB based on a head-to-head trial of patients with symptomatic femoropopliteal disease.
 
“I am very excited to see the Chocolate Touch, a next-generation drug coated balloon, is now available for patients across the United States.  This technology is an important tool in the armamentarium for the treatment of patients with peripheral artery disease,” Mehdi H. Shishehbor, DO, MPH, Ph.D., University Hospitals Harrington Heart & Vascular Institute, the Chocolate Touch trial’s co-principal investigator, told the press.
 
Chocolate Touch is a balloon catheter that integrates therapeutic agent delivery with its next-gen angioplasty platform to treat peripheral arterial disease. It’s designed to open in small sections using pillow-like structures coated with a therapeutic agent.
 
“This next generation paclitaxel DCB is based on the Chocolate mechanism of pillow-and-groove formation resulting in an increased balloon surface facilitating effective drug release to the vessel wall and potentially reducing the need for permanent implants.  The recently completed randomized, controlled study demonstrated excellent primary results, with statistical superior effectiveness as compared to the control drug coated balloon.  The Chocolate Touch is a drug coated balloon category of its own,” commented co-principal Investigator Professor Thomas Zeller, Universitaets-Herzzentrum, Bad Krozingen, Germany.
 
Genesis MedTech aims to launch this product in the U.S. via its G Vascular subsidiary.