QT Vascular, a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease, announced that it has submitted an investigational device exemption (IDE) for permission to begin the pivotal study of Chocolate Touch, its drug-coated balloon, in the US.

Chocolate Touch™ is the drug-coated version of the Company’s Chocolate® PTA balloon. Chocolate® PTA features a unique nitinol constraining structure that causes the balloon to open in a controlled uniform fashion, thus reducing acute trauma, dissections, and unplanned stenting compared to conventional PTA balloons1.

To complement these beneficial acute outcomes, the Company has added a proprietary coating of the drug, 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 without the need for a permanent implant such as a metallic stent.

"The Chocolate Touch™ pivotal study is the first of its kind to randomize against an existing drug coated balloon, the Lutonix device from CR Bard," stated Dr. Mehdi Shishehbor of the Cleveland Clinic, co-Principal Investigator.

"This state-of-the-art trial design combined with a next generation device is designed to provide physicians and patients the ability to compare treatment options and their performance."

The Chocolate Touch™ proposed US pivotal study is a prospective randomized study in the United States, Europe, and New Zealand that will evaluate patients with symptomatic, de novo disease in the superficial femoral and popliteal arteries. Patients will be randomized 1:1 to the 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 revascularization.

"This IDE submission is the culmination of years of careful product development, bench tests, pre-clinical experiments and clinical studies," stated Dr Eitan Konstantino, PhD, CEO of QT Vascular.

"This is a significant step for the Company on our path toward being one of the few players in the United States’ rapidly growing market for drug-coated balloons."

Drug-coated PTA balloons represent a new category of device that combines the mechanical dilatation of a balloon catheter with the biological effect of a drug to treat occluded arteries.

These devices have been available for several years in Europe and were recently approved in the US. Since their approval in the US, adoption has been increasing and CMS (Centers for Medicare and Medicaid Services) has granted additional reimbursement for these devices. According to some analyst estimates2, revenues for drug-coated balloons are expected to reach US$1 billion by 2020.

The Company’s Chocolate Touch™ received CE mark approval in July 2015. The Company has previously announced strong acute and 6 month outcomes in its feasibility study for Chocolate Touch™, ENDURE, with an incidence of bail-out stenting just 1.4%, a lumen loss of only 0.16mm, per-protocol primary patency of 90% and an incidence of clinically-driven target lesion revascularization of only 1.7%.

Commercial launch of Chocolate Touch™ in selected countries that are accepting CE mark is underway. The product is not yet approved for use in the US and the receipt of CE mark does not constitute such approval.