Singapore-based QT Vascular has obtained investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to conduct the US pivotal trial of its Chocolate Touch drug-coated balloon.
Chocolate Touch is the company’s second generation drug-coated version of the Chocolate PTA balloon.
The Chocolate PTA features a nitinol constraining structure that causes the balloon to inflate in a controlled uniform fashion which helps to reduce acute trauma, dissections, and unplanned stenting.
The company has added a patented drug coating containing the drug paclitaxel, to the Chocolate platform to avoid repeat procedures.
The combination of an atraumatic balloon platform and a therapeutic agent treats patients while reducing the need for a permanent implant.
Cleveland Clinic Dr Mehdi Shishehbor said: “Currently, available drug-coated balloons provide better patency compared to uncoated balloons.
“However, they are all based on Plain Old Balloon Angioplasty (POBA) platforms which induce acute arterial trauma and dissection.
“The Chocolate Touch is a second generation drug-coated balloon using an advanced platform that may allow patients to be treated while minimising the need for stents.”
The prospective, randomised Chocolate Touch US pivotal study will be conducted on patients with disease in the superficial femoral and popliteal arteries in the legs.
It will evaluate acute end points such as procedural successes and freedom from bail-out stenting, and long term endpoints such as patency and target lesion revascularisation while comparing the Chocolate Touch drug-coated balloon to that of CR Bard’s Lutonix drug-coated balloon.