Genesis MedTech Group has received approval for the treatment of peripheral artery disease (PAD) in the superficial femoral artery and popliteal artery with the Chocolate Touch Drug-coated Balloon (DCB) percutaneous transluminal angioplasty (PTA) Catheter from the US Food and Drug Administration (FDA).
Developed by TriReme Medical, Chocolate Touch is indicated for percutaneous transluminal angioplasty of de novo or restenotic lesions up to 180mm-long in native femoral or popliteal arteries with 4mm to 6mm vessel diameters, following suitable vessel preparation.
In August 2020, Genesis acquired the drug-device technology asset from TriReme.
It is claimed to be the first and only balloon catheter that integrates therapeutic agent delivery with a next-generation angioplasty platform to treat PAD.
Chocolate Touch has been designed with the aim of providing safe and effective treatment for peripheral vascular disease patients compared to traditional balloon angioplasty.
In a head-to-head, randomised trial, Chocolate Touch demonstrated statically better patency and non-inferior safety compared to Lutonix DCB at 12 months.
It also reported the lowest all-cause KM mortality value compared to the FDA-approved DCBs’ reported mortality in pivotal trials.
Genesis MedTech Group chairman and CEO Warren Wang said: “The Chocolate Touch FDA approval provides US physicians and their patients a next-generation drug-coated balloon with exceptional safety and efficacy to use in treating patients with PAD.
“This approval demonstrates our commitment to bring innovation solutions to enhance the standard of care of millions of patients suffering from peripheral vascular diseases.”
The company intends to commercialise the Chocolate Touch DCB in the US through its subsidiary, G Vascular.