Sorin Group has obtained marketing rights to its Mitroflow aortic pericardial heart valve in Japan, following the approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
The bioprosthetic heart valve, which is mounted with the pericardium layer on the outside wall, features an innovative design which makes it easy to suture and is designed for replacing diseased, damaged or malfunctioning prosthetic aortic valves.
Conformable to the native annulus and adaptable to difficult anatomies, the heart valve maximizes the internal orifice area allowing maximum valve opening with no obstruction to blood flow as well as an unimpeded leaflet opening.
During several long-term studies, the bioprosthetic heart valve has demonstrated ease of use and excellent hemodynamic performance, according to the company.
Osaka University Graduate School of Medicine cardiovascular surgery department professor Yoshiki Sawa said combined with excellent hemodynamic performance, the Mitroflow heart valve also provides patients with the benefits of long-term durability.
"Mitroflow’s low profile and ease of implant are ideally suited to Japanese patients who often have a small or narrow aortic root," Sawa added.
The company said the bioprosthetic heart valve will be distributed in Japan by its partner, Japan Lifeline.