TriReme Medical gets FDA approval for Chocolate PTCA balloon catheter

8 June 2014 (Last Updated June 8th, 2014 18:30)

QT Vascular's US subsidiary TriReme Medical has received US Food and Drug Administration approval to use its Chocolate PTCA balloon catheter for dilatation of the stenotic portion of the coronary artery or bypass graft stenosis.

QT Vascular's US subsidiary TriReme Medical has received US Food and Drug Administration approval to use its Chocolate PTCA balloon catheter for dilatation of the stenotic portion of the coronary artery or bypass graft stenosis.

The Chocolate PTCA is currently being used for treating patients with vascular disease in their legs and will now be used in improving myocardial perfusion.

Columbia University Center for Interventional Vascular Therapy director Martin Leon said: "It leverages the strong clinical outcomes and low rates of dissections of the Chocolate PTA balloon catheter, while providing an important new tool that could be now used in coronary arteries."

"It leverages the strong clinical outcomes and low rates of dissections of the Chocolate PTA balloon catheter, while providing an important new tool that could be now used in coronary arteries."

The device is designed to provide predictable and uniform dilatation of the coronary vasculature.

Clinical trials of the Chocolate PTA showed it having low rates of dissections and bail-out stenting; the PTCA has been developed on similar features, although there is no supporting clinical data available, said the company.

QT Vascular chief executive officer Eitan Konstantino said: "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."

QT Vascular is focused in the development and commercialisation of minimally invasive products for the treatment of vascular disease.