The US Food and Drug Administration (FDA) has granted QT Vascular full Investigational Device Exemption (IDE) approval to begin enrolling patients in the pivotal study of its Chocolate Touch drug-coated balloon. This follows the FDA’s granting of conditional IDE approval in September 2016.
The full IDE approval allows for enrolment up to 585 patients and up to 50 centres in the USA while additional patients may be enrolled in selected centres outside the country. The co-principal investigators of the study are Mehdi Shishehbor of the Cleveland Clinic and Thomas Zeller of the Heart Center in Bad Krozingen, Germany.
The Chocolate Touch US pivotal study is a prospective randomied study in the US, Europe, and New Zealand that will evaluate patients with disease in the superficial femoral and popliteal arteries in the legs. Patients will be randomised 1:1 to Bard’s Lutonix drug-coated balloon. The study 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 among others.
Chocolate Touch is the drug-coated version of the Company’s Chocolate percutaneous transluminal angioplasty balloon. Chocolate PTA features a nitinol constraining structure designed to cause the balloon to open in a controlled uniform fashion, thus reducing acute trauma, dissections, and unplanned stenting compared to conventional percutaneous transluminal angioplasty balloons.
For Chocolate Touch, QT Vascular has added a proprietary drug coating containing paclitaxel to the Chocolate platform, in order 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 minimising the need for a permanent implant.
Chocolate Touch received CE mark approval in July 2015. Commercial launch in selected accounts in countries that are accepting CE mark is underway.