The US Food and Drug Administration (FDA) has cleared TriReme Medical's expanded matrix of sizes for Glider PTCA balloon catheter.
Torqueable angioplasty Glider PTCA balloon catheter, which utilizes tip technology, is designed for the treatment of lesions in the coronary vasculature in balloon diameters from 1.5 – 3.5mm and in lengths from 4mm to 20mm.
Scottsdale Heart Group medical director and interventional cardiologist David Rizik said Glider provides interventional cardiologists with an entirely new degree of control during the treatment of complex side branches and total occlusions.
"With its torqueable shaft and ultra short 4mm length, I am amazed that such a clever design can provide such powerful clinical benefits," Rizik added.
TriReme Medical president and CEO Eitan Konstantino said the company’s recent experience in Europe demonstrates Glider’s ability to outperform conventional balloon catheters.
"TriReme now has three product families that have received regulatory approval in the United States," Konstantino added.
"I am proud of our development team that continues to bring to market ‘out-of-the-box’ solutions to simplify complex interventional procedures."