The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved Sorin Group's bioprosthetic heart valve, designed for replacing diseased, damaged or malfunctioning native or prosthetic aortic valves.
Mounted with the pericardium layer on the outside wall, the Mitroflow aortic pericardial heart valve maximises the internal orifice area, allowing maximum valve opening with no obstruction to blood flow as well as an unimpeded leaflet opening.
The heart valve, which is conformable to the native annulus and adaptable to difficult anatomies, features an innovative design that makes it easy to suture.
The valve has the ability to deliver excellent hemodynamic performance with low pressure gradients, large effective orifice areas and left ventricular mass regression, and also in patients with small annuli.
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 said.
Sorin Group Cardiac surgery Business Unit president Michel Darnaud said; "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."
The company said the bioprosthetic heart valve will be distributed in Japan by its partner, Japan Lifeline.
Image: Sorin bioprosthetic heart valve mounted with the pericardium layer on the outside wall replaces diseased, damaged or malfunctioning prosthetic aortic valves. Photo: Courtesy of Sorin Group.