The US Food and Drug Administration (FDA) has granted QT Vascular conditional Investigational Device Exemption (IDE) approval, allowing the company to begin enrolling patients in the pivotal study of its novel Chocolate Touch drug-coated balloon. The approval follows an extensive review by FDA of the Chocolate Touch technology including pre-clinical data, drug coating, bio safety, design features and clinical data.
“Currently, available drug-coated balloons provide better patency compared to uncoated balloons. However, they are all based on plain old balloon angioplasty platforms which induce acute arterial trauma and dissection. The Chocolate Touch is a second-generation drug-coated balloon using an advanced platform that may allow patients to be treated while minimising the need for stents,” stated Mehdi Shishehbor of the Cleveland Clinic, Cleveland, USA, co-principal investigator for the trial. “Previous studies showed the potential of this product at improving both acute and long-term outcomes. Now these promising earlier results will be studied in a much larger and more tightly controlled clinical trial setting.”
The Chocolate Touch US pivotal study is a prospective randomised study in the USA, 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 endpoints 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 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 of 1.4%, a lumen loss of 0.16mm, per-protocol primary patency of 90% and an incidence of clinically-driven target revascularisation of 1.7%. Commercial launch of Chocolate Touch in selected countries that are accepting CE mark is underway. The product is not approved for use in the USA.