17 July 2012 | Regulatory | By BioSpectrum Bureau
TriReme catheter gets FDA nod for expanded matrix
Singapore: TriReme Medical, medical device company with focus on the US and the emerging Asian markets, has received US FDA clearance for an expanded matrix of sizes for its unique Glider PTCA balloon catheter. Glider is now approved for the treatment of lesions in the coronary vasculature in balloon diameters from 1.5-3.5mm and in lengths from 4mm to 20mm.
"Glider provides interventional cardiologists with an entirely new degree of control during the treatment of complex side branches and total occlusions," said Dr David Rizik, medical director and interventional cardiologist at Scottsdale Heart Group in Scottsdale in the US. "With its torqueable shaft and ultra short 4mm length, I am amazed that such a clever design can provide such powerful clinical benefits. Glider has become my 'go-to' balloon when I approach the treatment of my most challenging cases."
"Our recent experience in Europe demonstrates Glider's ability to outperform conventional 'best in class' balloon catheters," said Mr Eitan Konstantino, president and CEO of TriReme Medical.
"TriReme now has three product families that have received regulatory approval in the US. I am proud of our development team that continues to bring to market outside-the-box solutions to simplify complex interventional procedures."