Chocolate Heart, which is the drug-coated version of the firm’s Chocolate PTCA balloon marketed in the US, has been developed for dilatation of the stenotic portion of coronary arteries to improve myocardial perfusion.

Drug-coated balloon is said to combine the mechanical dilatation of a balloon catheter with the biological effect of a drug to treat occluded arteries in the leg.

Chocolate PTCA features nitinol constraining structure, which enables balloon to open in a controlled uniform fashion to reduce acute trauma, dissections and unplanned stenting.

The PTCA balloon also features proprietary coating containing the paclitaxel drug, which will reduce the incidence of repeat procedures.

Chocolate Heart’s FIH study, which included 19 patients with de novo coronary lesions, was carried out at CECANOT Hospital in Santo Domingo, Dominican Republic.

According to the company, the incidence of acute closure was 0% compared to over 9% for conventional balloon angioplasty in hospital and after 30 days.

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 minimize 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."

QT Vascular is engaged in the development of drug-coated balloons for the treatment of both peripheral and coronary artery disease.

It has also developed Chocolate Touch drug-coated PTA balloon, which is not approved for use in the US.