TriReme Medical, a wholly-owned US subsidiary of QT Vascular, has received 510(k) approval from the US Food and Drug Administration (FDA) for its Chocolate PTCA balloon catheter in the US.
The FDA has granted the marketing approval for the Chocolate PTCA balloon catheter for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
The Chocolate PTCA balloon catheter is currently used to treat patients with peripheral arterial disease. In clinical studies, this device has demonstrated low rates of dissections and bail-out stenting. The device provides predictable and uniform dilatation of the coronary vasculature.
QT Vascular CEO Dr Eitan Konstantino said that the coronary business is an important element of the company’s 2015 growth.
"This new product approval demonstrates the team’s ability to effectively execute on our milestones. We look forward to working closely with physicians to generate clinical data and serve a larger patient population," Dr Konstantino added.