QT Vascular, a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease, announced the release of the interim results from ENDURE, the first study of its unique peripheral drug-coated balloon, Chocolate Touch.
Presenting at the annual meeting of the German Society of Angiology (DGA) in Freiburg, Germany, Professor Thomas Zeller of the Heart Center in Bad Krozingen, Germany and Co- Principal Investigator of the ENDURE study described the study findings in patients with above the knee disease at 6 months.
ENDURE is a prospective, core lab adjudicated study of the Chocolate Touch Paclitaxel drug- coated PTA balloon conducted at multiple sites in Germany and New Zealand. The study enrolled 67 patients (70 lesions) with above-the-knee disease and assessed outcomes at 30 days and 6 months.
There will also be a clinical and duplex ultrasound assessment of patients at 12 months. Unlike most other studies of drug-coated balloons, pre-dilatation was not required for Chocolate Touch and was left to the operator’s discretion. Angiographic results were adjudicated by the core lab at Yale University. Duplex ultrasound results were assessed by VASCORE.
"The patients enrolled in ENDURE represented similar demographics and lesions characteristics to the patients I treat in my everyday clinical practice. ENDURE results confirm that the Chocolate PTA platform induces very few flow-limiting dissections which leads to a very low rate of bail-out stenting", stated Professor Thomas Zeller.
"With the evidence of a very low rate of lumen loss and very few re-interventions at 6 months, we now have a drug-coated balloon that offers excellent acute and mid-term results in interventional treatment of TASC(1) II femoro- popliteal lesions."
Dr. Steven Kum, Vascular and Endovascular Surgeon at Mount Elizabeth Novena Hospital in Singapore added: "The mid-term results of the ENDURE trial are encouraging news for the Endovascular community. Re-narrowing after successful balloon angioplasty is a significant problem for us.
Drug-coated 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 United States.
Since their approval in the United States, adoption has been increasing and CMS (Centers for Medicare and Medicaid Services) has granted additional reimbursement for these devices. According to some analysts’ estimates(2), revenues for drug-coated balloons are expected to reach $1 billion by 2020.
"These results from ENDURE echo our experience in the Chocolate BAR registry which demonstrated low rates of dissections and unplanned stenting(3)", stated Dr. Eitan Konstantino, PhD, Chief Executive Officer of QT Vascular.
Commercial launch of Chocolate Touch in countries that are accepting CE mark is expected to commence later this year. The product is not approved for use in the United States and CE mark does not constitute such approval. The Group has also applied for CE marking approval with respect to the Chocolate Heart, its drug-coated coronary balloon.