Genesis MedTech Group announced that the Food and Drug Administration (FDA) has approved the Chocolate Touch drug-coated balloon (DCB) percutaneous transluminal angioplasty (PTA) catheter developed by TriReme Medical for the treatment of patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and the popliteal artery.
The Chocolate Touch DCB was shown to have statistically superior patency and non-inferior safety at 12 months as compared with Lutonix DCB based in a head-to-head, randomized trial of patients with symptomatic femoropopliteal disease.
The Chocolate Touch showed statistical 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 by Kaplan-Meier (KM) estimate 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 (MAEs) was 88.9% for those treated with the Chocolate Touch versus 84.6% for Lutonix DCB.
Additionally, 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 three years were 6.7% for the Chocolate Touch and 11.1% for the Lutonix DCB.
“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,” commented co-principal investigator Thomas Zeller, MD, from Universitaets-Herzzentrum in Bad Krozingen, Germany. “The recently completed randomized, controlled study demonstrated excellent primary results, with statistical superior effectiveness as compared to the control DCB. The Chocolate Touch is a DCB category of its own.”