QT Vascular has submitted an investigational device exemption (IDE) for permission to begin the pivotal study of the Chocolate Touch drug-coated balloon in the USA.
Chocolate Touch is the drug-coated version of the company’s Chocolate percutaneous transluminal angioplasty (PTA) balloon. QT Vascular says that 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 balloons”. To complement these beneficial acute outcomes, the company has added a proprietary coating of 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, according to a company press release.
“The Chocolate Touch pivotal study is the first of its kind to randomise against an existing drug coated balloon, the Lutonix device from CR Bard,” stated Mehdi Shishehbor of the Cleveland Clinic, USA, and 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 proposed pivotal study is a prospective randomised study in the USA, Europe, and New Zealand that will evaluate patients with symptomatic, de novo disease in the superficial femoral and popliteal arteries. Patients will be randomised 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 revascularisation.
“This IDE submission is the culmination of years of careful product development, bench tests, pre-clinical experiments and clinical studies,” stated Eitan Konstantino, chief executive officer of QT Vascular.
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 USA. Since their approval in the USA, adoption has been increasing and CMS (Centers for Medicare and Medicaid Services) has granted additional reimbursement for these devices. According to some analyst estimates, revenues for drug-coated balloons are expected to reach US$1bn by 2020.
The Chocolate Touch received CE mark approval in July 2015. The company has previously announced strong acute and six-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 revascularisation 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 USA.