The US Food and Drug Administration (FDA) has granted the full investigational device exemption (IDE) approval to Singapore-based QT Vascular to start enrolment for the pivotal study of its Chocolate Touch drug-coated balloon.
Chocolate Touch is the drug-coated version of the company's Chocolate PTA balloon, which features a nitinol constraining structure that causes the balloon to open in a controlled uniform fashion reducing acute trauma, dissections, and unplanned stenting compared to conventional PTA balloons.
The Chocolate Touch features a proprietary drug coating containing the drug paclitaxel which helps reducing the incidence of repeat procedures.
The combination of an atraumatic balloon platform and a therapeutic agent is designed to allow patients by minimising the need for a permanent implant.
QT Vascular CEO Eitan Konstantino 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."
The US prospective, randomised study is planning to enrol 585 patients with disease in the superficial femoral and popliteal arteries in the legs.
During the study, the patients will be randomised to be treated with CR Bard's Lutonix drug-coated balloon.
It will test acute end points such as procedural successes and freedom from bail-out stenting, and long term endpoints such as patency and target lesion revascularisation among others resulted after using the device.