Genesis MedTech Group announces 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 drug-coated balloon (DCB) was shown to have statistically 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.
- The Chocolate Touch showed statistically superiority in its primary efficacy endpoint of 12-month True DCB Success– a measure of the target vessel remaining patent without the need for bail-out stenting. Primary patency was 78.8% for Chocolate Touch and 67.7% for Lutonix DCB at 12mo (psuperiority=0.0386); by Kaplan-Meier (KM) estimate it was 83.3% for the Chocolate Touch and 73.0% for Lutonix DCB at 12 months
- The primary safety endpoint of 12-month freedom from major adverse events (MAE) was 88.9% for those treated with the Chocolate Touch versus 84.6% for Lutonix DCB (Pnon-inferiority <0.0001.
- Chocolate Touch results reported the lowest all-cause KM mortality value as compared to reported mortality for FDA approved DCBs in pivotal studies. Mortality rates for Chocolate Touch using KM estimates at 3 years were 6.7% for the Chocolate Touch and 11.1% for the Lutonix DCB.
“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. It 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.”
The company is planning to launch this product in the US through its subsidiary, G Vascular.
- MH Shishehbor, T Zeller, M Werner, M Brodmann, H Parise, A Holden, M Lichtenberg, SA Parikh, VS Kashyap, C Pietras, D Tirziu, S Ardakani, U Beschorner, P Krishnan, KA Niazi, AU Wali, AJ Lansky. Randomized Trial of Chocolate Touch Compared With Lutonix Drug-Coated Balloon in Femoropopliteal Lesions (Chocolate Touch Study). Circulation. 2022; 145: 1645–1654
- Creager MA, Loscalzo J. Chapter 275: Arterial Diseases of the Extremities. In: Jameson J, Fauci AS, Kasper DL, Hauser SL, Longo DL, Loscalzo J. eds. Harrison’s Principles of Internal Medicine. McGraw-Hill; Accessed August 28, 2020
[Source(s): Genesis MedTech, PR Newswire]