Full Approval Granted for Pivotal Trial of QT Vascular's Chocolate Touch Drug-Coated Balloon
December 16, 2016—QT Vascular Ltd. announced that the US Food and Drug Administration (FDA) has granted full approval of the investigational device exemption to enroll patients in the United States pivotal study of the Chocolate Touch drug-coated balloon (DCB) to treat peripheral artery disease in the superficial femoral and popliteal arteries. The full approval comes after receiving conditional IDE approval in September.
According to QT Vascular, the full IDE approval allows for enrollment up to 585 patients and up to 50 centers in the United States. Additional patients may be enrolled in selected centers outside the US. The Coprincipal Investigators of the study are Mehdi Shishehbor, MD, from the Cleveland Clinic in Cleveland, Ohio, and Prof. Thomas Zeller, MD, from the Heart Center in Bad Krozingen, Germany.
The prospective randomized Chocolate Touch United States pivotal study will be conducted in the United States, Europe, and New Zealand. Patients will be randomized 1:1 to the Lutonix DCB (Bard Peripheral Vascular). The study will evaluate acute endpoints such as procedural success and freedom from bailout stenting, and long-term endpoints such as patency and target lesion revascularization among others.
Chocolate Touch is the drug-coated version of the QT Vascular's Chocolate percutaneous transluminal angioplasty (PTA) balloon, which is commercially available in the United States. The Chocolate Touch includes a paclitaxel coating to reduce the incidence of repeat procedures. This combination of an atraumatic balloon platform and a proven therapeutic agent is intended to allow patients to be treated while minimizing the need for a permanent implant.
Chocolate Touch received European CE Mark approval in July 2015 and a commercial launch in selected countries is underway, advised QT Vascular.