QT Vascular said today it won full FDA investigational device exemption approval to initiate a trial of its Chocolate Touch drug-coated balloon designed to treat vascular disease.
The Singapore-based company said it looks to enroll 585 patients at up to 50 US centers for the prospective, randomized trial, which aims to explore the use of the device for treating patients with vascular disease in the superficial femoral and popliteral arteries in the legs.
The Chocolate Touch will be compared against Bard’s Lutonix drug-coated balloon, with acute study endpoints evaluating procedural success, freedom from bail-out stenting and long-term endpoints such as patency and target lesion revascularization, QT Vascular said.
“FDA appropriately set a high bar for this type of drug device combination product. We have worked hard to meet all conditions previously set by the FDA and are delighted to join a very small group of companies able to reach this point with a drug-coated balloon,” CEO Eitan Konstantino said in a press release.
The device won the CE Mark for treating peripheral artery disease in September 2015 and in July it won approval for treating coronary artery disease. The Chocolate Touch is the drug-coated version of the company’s Chocolate PTA balloon, which has FDA clearance and is available in the US.
QT Vascular won initial FDA IDE approval for the trial in September.