FDA Approves Pivotal Trial for QT Vascular's Chocolate Touch Drug-Coated Balloon

September 21, 2016—QT Vascular Ltd. has announced that the US Food and Drug Administration (FDA) granted the company conditional investigational device exemption approval to begin enrolling patients in the pivotal study of its Chocolate Touch drug-coated balloon (DCB). The approval follows an extensive review by the FDA of the Chocolate Touch technology including preclinical data, drug coating, bio safety, design features, and clinical data.

Mehdi Shishehbor, MD, who is Coprincipal Investigator of the study, commented in QT Vascular’s announcement, “Currently, available DCBs 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 DCB using an advanced platform that may allow patients to be treated while minimizing the need for stents."

Dr. Shishehbor, who is with the Cleveland Clinic in Cleveland, Ohio, added, “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 United States pivotal study is a prospective randomized study in the United States, Europe, and New Zealand that will evaluate patients with disease in the superficial femoral and popliteal arteries. Patients will be randomized 1:1 to the Chocolate Touch DCB or the Lutonix DCB (Bard Peripheral Vascular, Inc.). The study will evaluate acute endpoints such as procedural success and freedom from bailout stenting, as well as long-term endpoints such as patency and target lesion revascularization.

QT Vascular’s Chocolate Touch, which received European CE Mark approval in 2015, is the paclitaxel-coated version of the company’s Chocolate PTA balloon and features a nitinol constraining structure that causes the balloon to open in a controlled, uniform fashion to reduce acute trauma, dissections, and unplanned stenting.

The company has previously announced acute and 6-month outcomes in its ENDURE feasibility study for Chocolate Touch. Results included a 1.4% incidence of bailout stenting, a lumen loss of 0.16 mm, per-protocol primary patency of 90%, and a 1.7% incidence of clinically driven target lesion revascularization.