QT Vascular has received CE mark clearance for the sale and distribution of its Chocolate Heart drug-coated balloon for dilatation of the stenotic portion of coronary arteries for the purpose of improving myocardial perfusion in Europe. The device is the drug-coated version of the company’s percutaneous transluminal coronary angioplasty (PTCA) Chocolate balloon that has been commercially available in the USA since late 2014.
A press release reports that the Chocolate PTCA balloon features a unique nitinol constraining structure that causes the balloon to open in a controlled uniform fashion, thus is designed to reduce acute trauma, dissections, and unplanned stenting compared to conventional balloons. Initial evidence of this has previously been demonstrated in a trial of the peripheral version of device, known as Chocolate PTA or “Chocolate BAR”. QT Vascular has added a proprietary coating containing the proven drug, paclitaxel, to the Chocolate PTCA platform to reduce the incidence of repeat procedures. This combination of an atraumatic balloon platform and a proven therapeutic agent is intended to allow certain patients to be treated with Chocolate Heart while avoiding the need for a permanent implant such as a metallic stent.
The first-in-human study of Chocolate Heart was conducted at CECANOT Hospital in Santo Domingo, Dominican Republic in 19 patients with de novo coronary lesions. The results of this novel study were recently presented by the intravenous ultrasound (IVUS) core lab principal investigator, Alexandre Abizaid (Dante Pazzanese Hospital in Sao Paolo, Brazil). In-hospital and after 30 days, the incidence of acute closure was 0% compared to over 9% for conventional balloon angioplasty. At six months, the late lumen loss was only 0.01mm with a rate of target lesion re-treatment of only 5%. Abizaid says: “For a small first-in-human study, these results are very promising. The late lumen loss is much lower compared to conventional balloon therapies, including stents. I’m looking forward to additional larger studies that may confirm the benefit of this exciting new treatment option for patients suffering from coronary artery disease.”