Genesis MedTech’s Chocolate Touch DCB Evaluated for PTA in SFA and Popliteal Disease

April 4, 2022—The American College of Cardiology (ACC) announced the presentation of findings from an evaluation of the second-generation paclitaxel-coated Chocolate Touch device (Genesis MedTech International) in patients undergoing percutaneous transluminal angioplasty (PTA) for superficial femoral artery (SFA) and popliteal artery disease.

The study enrolled 313 patients at 34 sites in four countries who were undergoing PTA, with a follow-up rate of 94%. Patients were randomized to receive either the Chocolate Touch device or the Lutonix drug-coated balloon (DCB) catheter (BD Interventional).

The results were presented at ACC.22, the ACC’s 71st annual scientific session held April 2-4 in Washington, DC, and simultaneously published by Mehdi H. Shishehbor, DO, et al online in Circulation.

According to ACC, the primary efficacy endpoint was noninferiority of the Chocolate Device versus the Lutonix device, determined based on patency of the artery without the need for additional procedures at 12 months. Safety endpoints included major adverse events at 12 months, defined using a composite of mortality related to the affected limb, major amputation, and revascularization procedures.

Chocolate Touch was found at 12 months to be noninferior to Lutonix, with 78.8% of patients in the Chocolate Touch group achieving patency without additional procedures versus 67.7% of those in the Lutonix group, reported ACC.

There were no significant differences between the Chocolate Touch and Lutonix in terms of safety, with major adverse events occurring in 11.1% of patients receiving Chocolate Touch versus 15.4% in those receiving Lutonix. The estimated 3-year mortality rate was 6.8% in patients receiving the Chocolate Touch device, which was below the trial's goal of 13.2%.

The investigators concluded that the Chocolate Touch device is superior to Lutonix for efficacy with a similar safety profile. They noted that future research should look at whether the Chocolate Touch device has an even greater advantage in treatment of longer.

“At a minimum, this [Chocolate Touch] device is as safe as the Lutonix, with a trend for lower mortality rates,” commented Dr. Shishehbor in the ACC press release. “As we advance our technologies and get more patency, or blood flow, over time, the patients will enjoy that benefit and have a lower likelihood of needing repeat procedures. I think that the superiority of Chocolate Touch indicates that as we improve the technologies, there is additional benefit to be gained.”

In August 2020, Genesis MedTech International acquired the Chocolate Touch device from TriReme Medical LLC, a wholly owned subsidiary of QT Vascular Ltd. Chocolate Touch is the drug-coated version of the Chocolate PTA balloon, which was acquired by Medtronic from QT Vascular in January 2018 and is commercially available in the United States. The study was funded by TriReme Medical.

Chocolate Touch received European CE Mark approval in 2015. In the United States, it can be used only in an investigational device exemption clinical study.