Century Medical Inc., the Japanese partner of TriReme Medical Inc., has obtained Shonin approval for the GliderXtreme PTA catheter, a device designed for the treatment of peripheral arterial blockages.
Featuring a low-profile nitinol shaft and a slide-lock design, the GliderXtreme targets complex lesions in the distal peripheral vasculature, executives said. The features of GliderXtreme PTA catheter produce a balloon catheter with exceptional pushability and crossability.
TriReme Medical President/CEO Dr. Eitan Konstantino noted peripheral arterial disease is a growing health care concern in Asia.
"GliderXtreme was custom designed to meet the clinical needs and exacting standards of the Japanese marketplace. We are proud to receive this regulatory approval. This milestone represents yet another step in the Asia-focused expansion strategy of TriReme," he said.
Century Medical president and CEO Akira Hoshino pointed out that GliderXtreme will enable Japanese physicians to treat complex lesions both above and below the knee.
"This is the second product approved as a result of our collaboration with TriReme Medical," Hoshino added.
Based in Singapore and Pleasanton, Calif., TriReme Medical is a privately held company that develops, manufactures and commercializes next-generation percutaneous medical devices for the treatment of complex coronary and peripheral arterial disease. Focused on the United States and emerging Asian markets, TriReme recently announced a strategic partnership with Weigao, a major medical device firm in China.
Tokyo, Japan-headquartered Century Medical is a $140 million subsidiary company of Itochu Corporation, a $115 billion international trading company. The firm employs roughly 300 people and specializes in the importation, sale and marketing of advanced single-use and implantable medical devices.