Sorin Group has announced that it has received the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approval for the Mitroflow Aortic Pericardial Heart Valve.
Long-term studies (21 years) and 30 years of clinical use of the Mitroflow valve have demonstrated excellent haemodynamic performance, great durability and ease of use.1, 2 The valve is easy to suture, conformable to the native annulus and adaptable to difficult anatomies1,3.
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 delivers excellent haemodynamic performance with low pressure gradients, large effective orifice areas and left ventricular mass regression also in patients with small annuli.
“I am very pleased that the Mitroflow valve is now available in Japan. Mitroflow’s low profile and ease of implant are ideally suited to Japanese patients who often have a small or narrow aortic root. In addition, Mitroflow provides patients with the benefits of long-term durability combined with excellent haemodynamic performance,” said Yoshiki Sawa, Department of Cardiovascular Surgery at Osaka University Graduate School of Medicine, in Suita, Japan.
The Mitroflow aortic pericardial heart valve will be distributed in Japan by JLL, Japan Lifeline.
1 CA Yankah, et al. Aortic valve replacement with the Mitroflow pericardial bioprosthesis: Durability results up to 21 years. J Thorac Cardiovasc Surg. 2008;136:688-696
2 The ISTHMUS Investigators. The Italian study on the Mitroflow postoperative results (ISTHMUS): a 20-year, multicentre evaluation of Mitroflow pericardial bioprosthesis. European Journal of Cardio-thoracic Surgery 39 (2011) 18-26
3 WRE Jamieson, et al. Hemodynamic performance of mitroflow aortic pericardial bioprosthesis – optimizing management for the small aortic annulus. Thorac Cardiovasc Surg. 2010 Mar;58(2):69-75