QT Vascular Ltd., a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease, announced that the Food and Drug Administration has granted it conditional Investigational Device Exemption (IDE) approval.
This approval allows 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 (POBA) 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 minimizing the need for stents,” stated Dr. Mehdi Shishehbor of the Cleveland Clinic, co-principal investigator. “Previous studies1,2 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 U.S. 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 in the legs. Patients will be randomized 1:1 to CR 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 revascularization among others.
“We are thrilled to receive this conditional IDE approval from FDA,” stated Eitan Konstantino, Ph.D., CEO of QT Vascular. “This approval concludes a highly sophisticated research effort and marks a significant step towards joining the exclusive list of companies able to sell drug-coated balloons in the U.S.”
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 excellent acute outcomes, the Company has added a proprietary drug coating containing 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 while minimizing the need for a permanent implant.
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 to create a second generation of drug-coated balloons. These devices have been available for several years in Europe and were recently approved in the U.S. Since their approval in the U.S., adoption has been increasing and CMS (Centers for Medicare and Medicaid Services) has granted additional reimbursement for these devices. According to some analyst estimates3, revenues for drug-coated balloons are expected to reach $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 percent, a lumen loss of only 0.16 mm, per-protocol primary patency of 90 percent and an incidence of clinically driven target lesion revascularization of only 1.7 percent. Commercial launch of Chocolate Touch in selected countries that are accepting CE mark is underway. The product is not approved for use in the U.S. and CE mark does not constitute such approval. For more information: www.qtvascular.com.
1. Chocolate BAR interim results presented by Mustapha (AMP, August 2015)
2. ENDURE interim results presented by Zeller (German Society of Angiology, September 2015)
3. Morningstar (July 30, 2015)
(Source: PR Newswire)