Sorin Group, a medical products group based in Italy, announced that it had received approval from the Japanese Pharmaceuticals and Medical Devices Agency for the company’s Mitroflow aortic pericardial heart valve. Now that the device has been approved in Japan, Sorin Group will launch its heart valve product line in the country.
According to a press release by the company, the Mitroflow aortic pericardial heart valve is designed for surgical implantation as a replacement for a patient’s aortic valve. Patients with a form of heart disease known as aortic stenosis will benefit from the device. After receiving approval from the Japanese Pharmaceuticals and Medical Devices Agency, Sorin Group further announced that it had signed a new distribution deal for the heart valve technology with Japan Lifeline Co. Ltd.
Michel Darnaud is the president of the cardiac surgery unit at Sorin Group. In prepared remarks, he stated, "The PMDA approval of the Mitroflow valve in Japan is a key achievement for Sorin Group.” He continued, “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."
Sonin Group has significant operations in the United States, Japan and France. In addition to replacement heart valves, the company manufacturers heart-lung machines, cannulae, blood management tools, oxygenators and cardiothoracic surgery accessories.