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CATALIST-LISTED QT Vascular says it has received the CE mark clearance for the sale and distribution of the Chocolate Heart drug-coated PTCA balloon for dilatation of the stenotic portion of coronary arteries for the purpose of improving myocardial perfusion in Europe.
In a filing to the local bourse on Thursday, it said Chocolate Heart is the drug-coated version of the company's Chocolate PTCA balloon that has been commercially available in the United States since late 2014.
Drug-coated balloons represent a rapidly growing new category of device that combines the mechanical dilatation of a balloon catheter with the biological effect of a drug to treat occluded arteries in the leg. These devices have been available for several years in Europe and were recently approved in the US, the group said.
The company believes that drug-coated balloons may also play an important role in the future in the treatment of patients with disease in their coronary arteries.
Said Eitan Konstantino, chief executive of QT Vascular: "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."
QT Vascular is developing drug-coated balloons for the treatment of both peripheral and coronary artery disease.
Its Chocolate Touch drug-coated PTA balloon received CE mark approval in July 2015. The commercial launch of Chocolate Touch in selected countries that are accepting CE mark is underway.