QT Vascular has announced that it has enrolled the first European patients in the ENDURE trial in Germany. Multiple patients have already been enrolled in this study by Andrew Holden, at Auckland City Hospital, Auckland, New Zealand.
ENDURE is a single-arm core-lab adjudicated multicentre clinical trial conducted at top centres in Europe and New Zealand. ENDURE is designed to evaluate the efficacy of Chocolate Touch at 30 days, three, six and 12 months. Clinical assessment will include amputation free survival and Rutherford grade change while core lab measurements will include late lumen loss, patency and target lesion revascularisation.
Chocolate Touch is a novel drug-coated peripheral balloon that combines the acute benefits of the Chocolate PTA balloon catheter with the potential long-term benefits of a paclitaxel-based coating. The Chocolate platform represents a breakthrough in angioplasty balloon catheters. Used for the treatment of patients with peripheral arterial disease, it was designed to provide predictable, uniform, less traumatic dilatation and has demonstrated a very low rate of dissections and bailout stenting. According to QT Vascular, in addition to the benefits of the underlying Chocolate Platform, Chocolate Touch is different from other drug-eluting balloons as it does not require pre-dilatation and has a larger contact surface for drug transfer.
In the first European patient treated at the Department of Angiology at Universitats—Herzzentrum Freiburg, Bad Krozingen, Germany, a 6.0x40mm Chocolate Touch was used to successfully dilate a subtotal occlusion of the superficial femoral artery. “Chocolate’s mechanism of action minimises vessel trauma and therefore reduces the chances of a dissection. Now coupled with a drug it could provide an option for patients to leave the hospital without a permanent implant,” stated Thomas Zeller, head, Department of Angiology.
QT Vascular previously announced on 24 July 2014, that it has applied for CE marking approval for the Chocolate Touch. The CE mark approval, which is not expected this year, will allow for marketing of the product in the European Union. This will allow QT Vascular to capitalise on the positive demand for medical devices in Europe and the world. Chocolate Touch will be the latest addition to the company’s product pipeline. Prior to this, QT Vascular had announced (on 5 June 2014) that its wholly owned US subsidiary, TriReme Medical, received notification from the FDA of 510(k) clearance to market the Chocolate Percutaneous Transluminal Coronary Angioplasty Balloon Catheter (“Chocolate PTCA”) in the United States, for the treatment of blocked arteries for coronary vascular diseases. Other products in the pipeline include the Silk PTA balloon catheter, a version of Chocolate PTA that is made for intervention in longer lesions. The Silk PTA is currently at the design feasibility stage, with CE mark submission targeted for the first quarter of 2015.
Eitan Konstantino, the company’s chief executive officer, commented, “”We are very excited to expand the ENDURE trial in Europe and expect the enrolment to be faster with additional world class sites joining the study. It is very satisfying to see patients leaving the hospital without having to live with metal left in their leg for the rest of their life. I believe that this is where the field is trending and this is consistent with our vision. Chocolate Touch represents a key milestone towards the commercialization of our second generation drug-coated balloons and will keep us competitive in the medical device market for peripheral artery diseases.”