Genesis MedTech Group announced today 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.
- 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.
The Chocolate Touch drug-coated balloon 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.
The company is planning to launch this product in the U.S. through its subsidiary, G Vascular.