QT Vascular has secured conditional investigational device exemption (IDE) approval from the US Food and Drug Administration to begin the pivotal study of its new Chocolate Touch drug-coated balloon.
The study will assess patients with disease in the superficial femoral and popliteal arteries in the legs.
The approval enables the company to enroll patients in the prospective randomized study that will be carried out in the US, Europe, and New Zealand.
The IDE approval was based on the Chocolate Touch technology’s pre-clinical and clinical data, as well as drug coating, bio safety and design features.
In the study, the company will randomize patients in 1:1 ratio to CR Bard's Lutonix drug-coated balloon.
The trial will assess acute end points such as procedural successes and freedom from bail-out stenting, as well as long term endpoints such as patency and target lesion revascularization.
The study co-principal investigator Dr Mehdi Shishehbor said: "We are thrilled to receive this conditional IDE approval from FDA.
"This approval concludes a highly sophisticated research effort and marks a significant step towards joining the exclusive list of companies able to sell drug-coated balloons in the US."
Chocolate Touch is the drug-coated version of the firm’s Chocolate PTA balloon, which features an advanced nitinol constraining structure that causes the balloon to open in a controlled uniform manner.
It helps to reduce acute trauma, dissections, and unplanned stenting compared against conventional PTA balloons.
In addition, the company has added drug coating containing the drug paclitaxel to the Chocolate platform to reduce the incidence of repeat procedures.