TriReme Medical, Inc. Receives FDA 510(k) Clearance for a Broad Matrix of GliderXtreme(TM) PTA Balloon Catheter Sizes
PLEASANTON, Calif., May 17 /PRNewswire/ -- TriReme Medical, Inc. (TMI) announced today that it has received FDA clearance for an expanded matrix of sizes for its GliderXtreme™ PTA balloon catheter. GliderXtreme™ is now approved for the percutaneous transluminal treatment of lesions in the peripheral vasculature in balloon diameters from 2.0 – 5.0mm and in balloon lengths up to 200mm.
Peripheral arterial disease (PAD) is a large unmet clinical need and a growing public health issue. Approximately 12 million Americans suffer from PAD, which can lead to chronic pain, significant mobility limitations, and a decreasing quality of life. Left untreated, PAD can lead to limb loss and even death. Current device therapies have shortcomings in the challenging peripheral environment resulting in low rates of acute and long-term success.
"With this expanded clearance of the GliderXtreme™, we now have the ability to offer a broad range of sizes to US physicians and hospitals," said Eitan Konstantino, Ph.D., President and CEO of TMI. "We expect to launch GliderXtreme™ in the US this summer and to offer physicians a new and differentiated platform for peripheral intervention."
Gregory D. Casciaro, former CEO of XTENT and industry veteran who recently joined TMI's board of directors added, "I am delighted to be working with such an innovative company. GliderXtreme™ is the first in a series of products developed by TMI that directly address important unmet clinical needs. It has the potential to become the new standard for physicians treating today's patients with complex vascular disease."
An advanced product with specific features for the PAD therapy market, GliderXtreme™ has a unique configuration that allows exceptional push, even in very long balloons that traditionally suffer from limited performance. Combined with its a-traumatic tapered tip and shaft construction reinforced for torque transmission, GliderXtreme™ is designed to cross distal, long, tight lesions to restore blood flow in complex peripheral anatomy.
About TriReme Medical, Inc.
Based in Pleasanton, California, TriReme Medical, Inc. (TMI) is a privately held medical device company dedicated to the development, manufacturing, and commercialization of advanced therapeutic solutions for the treatment of complex vascular disease. The Company's novel balloon and stent products are specifically designed for the treatment of large unmet clinical needs.
TMI can be contacted at +1 (925) 931-1300 or firstname.lastname@example.org.
SOURCE TriReme Medical, Inc.