Interim Results Presented for QT Vascular's Chocolate Touch

October 6, 2015—QT Vascular Ltd. announced the release of the interim results from ENDURE, the first study of the company’s Chocolate Touch peripheral drug-coated balloon to treat patients with above-the-knee peripheral artery disease. ENDURE coprincipal investigator Prof. Thomas Zeller, MD, of the Heart Center in Bad Krozingen, Germany, presented the 6-month data at the annual meeting of the German Society of Angiology in Freiburg, Germany.

ENDURE is a prospective, core lab–adjudicated study of the Chocolate Touch paclitaxel-coated percutaneous transluminal angioplasty 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.

In September, QT Vascular announced European CE Mark approval for the Chocolate Touch. Commercial launch of the device in countries that recognize CE Mark is expected to commence later this year. The product is not approved for use in the United States. California-based TriReme Medical LLC is a subsidiary of QT Vascular, which is based in Singapore, and is the developer and manufacturer of the Chocolate Touch device.

According to the company, Prof. Zeller reported a 100% (70/70) technical success rate (defined as the ability to deliver and inflate Chocolate Touch at the intended location), 98.6% (68/69) device success rate; and 100% (70/70) procedural success rate. There was a 1.4% rate (1/69) of adjudicated bailout stenting.

At 6 months, there was an average 2.5 class improvement in Rutherford class, a clinically driven target lesion revascularization rate of 1.7% (1/60), a primary patency (per protocol) rate of 90% (45/50), and average late lumen loss of 0.16 mm.

The company noted predilatation 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 and duplex ultrasound results were assessed by VASCORE.

In QT Vascular’s press release, Prof. Zeller commented, “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 bailout stenting. With the evidence of a very low rate of lumen loss and very few reinterventions at 6 months, we now have a drug-coated balloon that offers excellent acute and midterm results in interventional treatment of TASC II femoropopliteal lesions.”

Steven Kum, MD, a vascular and endovascular surgeon at Mount Elizabeth Novena Hospital in Singapore, added, “The midterm results of the ENDURE trial are encouraging news for the endovascular community. Renarrowing after successful balloon angioplasty is a significant problem for us. Drug-eluting technology to reduce renarrowing, in combination with the Chocolate balloon, could usher a new ‘nonstent’ paradigm in the way we treat patients. The Chocolate Touch can potentially be applied to a wide range of lesions, and we await the long-term results and its availability in Singapore.”