Sorin Group (BIT:SRN) said it plans to launch its Mitroflow heart valve in Japan now that a regulatory body there has approved its use.
The Japanese Pharmaceuticals and Medical Devices Agency OK’d the aortic pericardial heart valve, which is surgically implanted to replace the aortic valve in patients with aortic stenosis, according to a press release.
Sorin said it’s already inked a deal for distribution in Japan with Japan Lifeline Co. Ltd.
"The PMDA approval of the Mitroflow valve in Japan is a key achievement for Sorin Group," cardiac surgery unit president Michel Darnaud said in prepared remarks. "Sorin Group is strongly committed to improving patient outcomes and we are pleased to provide Japanese patients and cardiothoracic surgeons with a state-of-the-art therapy for aortic valve replacement."
