Mitroflow receives PMDA approval; launches in Japan
Sorin has received the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approval for the Mitroflow aortic pericardial heart valve. The product will be distributed in Japan by Japan Lifeline Company.
With the pericardium layer mounted on the outside of valve stent, the Mitroflow valve maximises the internal orifice area, allowing for maximum valve opening with no obstruction to blood flow and an unimpeded leaflet opening. The valve is said to deliver excellent haemodynamic performance with low pressure gradients, large effective orifice areas and left ventricular mass regression also in patients with small annuli.