Genesis MedTech’s Chocolate Touch DCB Approved by FDA for Treatment of PAD

November 11, 2022—Genesis MedTech Group announced that the FDA has approved the company’s Chocolate Touch drug-coated balloon (DCB) percutaneous transluminal angioplasty (PTA) catheter for the treatment of patients with peripheral artery disease in the superficial femoral artery and the popliteal artery. The company is planning to launch the Chocolate Touch DCB in the United States through its subsidiary, G Vascular.

Genesis MedTech’s advised that the Chocolate Touch paclitaxel DCB catheter is indicated for PTA, after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native femoral or popliteal arteries with reference vessel diameters of 4 to 6 mm.

The Chocolate Touch device was developed by TriReme Medical LLC. In August 2020, Genesis MedTech announced the completion of its acquisition of the Chocolate Touch DCB from TriReme Medical, a wholly owned subsidiary of QT Vascular Ltd.

According to Genesis MedTech, the Chocolate Touch DCB was shown to have statistically superior patency and noninferior safety at 12 months as compared with the Lutonix DCB (BD Interventional) based on the results from the CHOCOLATE TOUCH study, a randomized trial of patients with symptomatic femoropopliteal disease. These results were presented in April at ACC.22, the American College of Cardiology’s 71st annual scientific session and published by Mehdi H. Shishehbor, DO, et al in Circulation (2022;145:1645-1654).

Dr. Shishehbor and Professor Thomas Zeller, MD, are Coprincipal Investigators of the CHOCOLATE TOUCH trial. Dr. Shishehbor is with the University Hospitals Harrington Heart & Vascular Institute in Cleveland, Ohio. Prof. Zeller is with Universitaets-Herzzentrum, Freiburg-Bad Krozingen, in Bad Krozingen, Germany.

As outlined in the company’s press release, the results included the following:

• 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 was 78.8% for Chocolate Touch versus 67.7% for Lutonix DCB at 12 months (P = .0386 for superiority); by Kaplan-Meier (KM) estimate, primary patency 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 was 88.9% for Chocolate Touch versus 84.6% for Lutonix DCB (P < .0001 for noninferiority).
• Mortality rates using KM estimates at 3 years were 6.7% for the Chocolate Touch and 11.1% for the Lutonix DCB. The company noted that the reported Chocolate Touch results were the lowest all-cause KM mortality value as compared to reported mortality for FDA-approved DCBs in pivotal studies.

“I am very excited to see the Chocolate Touch, a next-generation DCB, is now available for patients across the United States,” commented Dr. Shishehbor in the company’s press release. “This technology is an important tool in the armamentarium for the treatment of patients with peripheral artery disease.”

Prof. Zeller added, “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 DCB. The Chocolate Touch is a DCB category of its own.”