Singapore-based QT Vascular has secured the CE Mark for its Chocolate Heart drug-coated PTCA balloon for dilatation of the stenotic portion of coronary arteries for an improved myocardial perfusion of patients in Europe.
Chocolate Heart is the drug-coated version of QT Vascular's Chocolate PTCA balloon, which features a nitinol constraining structure that inflates the balloon in a controlled uniform fashion, minimising acute trauma, dissections, and unplanned stenting compared to conventional balloons.
The new balloon version features the company's patented coating containing proven drug paclitaxel to reduce incidences of repeat procedures.
The combination of an atraumatic balloon platform and a proven therapeutic agent allows the patients to be treated with Chocolate Heart, while eliminating the need for a permanent implant such as a metallic stent.
QT Vascular CEO Eitan Konstantino said: "We are delighted with the CE Mark clearance of our novel Chocolate Heart drug-coated PTCA balloon.
"The opportunity to minimise the use of metallic stents is greater in the coronary compared to any other arteries.
"We intend to increase our focus on the coronary business and build evidence to help improve patients care."
A study conducted on Chocolate Heart which involved 19 patients with de novo coronary lesions has displayed that the incidence of acute closure was 0% compared to more than 9% for conventional balloon angioplasty.
At six months of the study, the late lumen loss was 0.01mm with a rate of target lesion re-treatment of only 5%.