QT Vascular has secured full investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to start a trial of its new Chocolate Touch drug-coated balloon.
In September this year, the company received conditional IDE approval from the FDA to begin the study of Chocolate Touch drug-coated balloon.
The full IDE approval enables the firm to recruit around 585 patients at 50 centers in the US, as well as additional patients in selected centers outside the US.
Cleveland Clinic's Mehdi Shishehbor and Germany-based Heart Center’s professor Thomas Zeller are the co-principal investigators of the study.
The Chocolate Touch US pivotal study is a prospective randomized study in the US, Europe, and New Zealand, which will assess patients with disease in the superficial femoral and popliteal arteries in the legs.
The firm 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, in addition to long term endpoints such as patency and target lesion revascularization.
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.
The balloon will enable to reduce acute trauma, dissections, and unplanned stenting compared against PTA balloons.
The company has added drug coating containing the drug paclitaxel to the Chocolate platform to reduce the incidence of repeat procedures.
QT Vascular CEO Dr 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."
Image: QT Vascular has secured full IDE approval from FDA to begin study of the Chocolate Touch drug-coated balloon. Photo: courtesy of jk1991 at FreeDigitalPhotos.net.