Singapore medical device maker and QT Vascular subsidiary TriReme Medical won FDA clearance for its Chocolate PTCA balloon catheter, the latest in the company’s line of minimally invasive vascular disease treatment products.
FDA regulators granted clearance for use in dilating narrowed coronary arteries or during myocardial perfusion, although there is no clinical data yet available on the new device, according to a press release.
The technology builds on TriReme’s Chocolate PTA balloon catheter, using the same engineering principles. The older PTA device is indicated for treatment of vascular disease in the legs.
"The coronary business is an important element of our 2015 growth. This new product approval demonstrates the team’s ability to effectively execute on our milestones," QT Vascular CEO Dr. Eitan Konstantino said in prepared remarks. "We look forward to working closely with physicians to generate clinical data and serve a larger patient population."