Genesis MedTech Group announced that the Food and Drug Administration (FDA) has approved the Chocolate Touch Drug-coated Balloon PTA Catheter, developed by TriReme Medical LLC, for the treatment of patients with peripheral artery disease in the superficial femoral artery and the popliteal artery.
The Chocolate Touch® drug-coated balloon (DCB) was shown to have statically superior patency and non-inferior safety at 12 months as compared with Lutonix® DCB based on a head-to-head, randomized trial of patients with symptomatic femoropopliteal disease.
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“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,” stated Mehdi H. Shishehbor, DO, MPH, PhD, University Hospitals Harrington Heart & Vascular Institute, Cleveland, OH, the Chocolate Touch trial’s Co-Principal Investigator.
The Chocolate Touch® drug-coated balloon is the world’s first and only balloon catheter that integrates therapeutic agent delivery with the next generation angioplasty platform, for the treatment of peripheral arterial disease. Chocolate Touch® is designed to open in small sections using pillow-like structures coated with a therapeutic agent. With the goal of providing patients suffering from peripheral arterial disease with an alternative treatment to traditional drug-coated balloon angioplasty.
“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.
Warren Wang, Chairman and CEO of Genesis MedTech Group said, “The Chocolate Touch® FDA approval provides U.S. physicians and their patients a next-generation drug-coated balloon with exceptional safety and efficacy to use in treating patients with PAD. This approval demonstrate our commitment to bring innovation solutions to enhance the standard of care of millions of patients suffering from peripheral vascular diseases.”