FDA approves TMI’s Glider PTCA Catheter

TriReme Medical, Inc. (TMI) today announced approval by the U.S. Food and Drug Administration (FDA) of the Glider™ PTCA Catheter, indicated for treating the stenotic portion of coronary arteries or bypass grafts to improve myocardial perfusion.

Glider™ is the world's only torqueable PTCA balloon catheter. Combined with its state of the art tip technology, Glider™ is designed to perform, even in the most challenging conditions. It is also available in an ultra short balloon length of 4mm designed for focal lesions.

In a related piece of news, William L. Lombardi, MD of PeaceHealth St. Joseph Medical Center, Bellingham, WA performed the first case using Glider in the United States. "I was able to successfully use Glider to dilate a focal side branch lesion in a complex case and achieve a great outcome without the use of kissing balloons," stated Dr. Lombardi. "I am delighted to be the first Glider user in the US and believe that Glider presents a new and effective way of navigating through complex lesions."

"There has been very little innovation in balloons and catheter technology in the past decade and TriReme's innovative portfolio stands out," said James Hermiller, MD, director of the Interventional Fellowship at St. Vincent Heart Center of Indiana in Indianapolis. He added: "The newly approved ultra short balloon may be very useful for focal lesions and side branches. Combined with its crossing ability and the stable shaft, I can see it becoming a key tool in these types of cases."

"Glider is the latest addition to our portfolio of innovative PTA and PTCA devices that also includes the GliderXtreme™, GliderfleX® and Chocolate™", said Eitan Konstantino, Ph.D., President and Chief Executive Officer of TMI. "Those products are approved in the US and we are well underway to start getting approvals in our key targeted markets of Japan and China."