Tuesday, June 12, 2018
LivaNova PLC, a market-leading medical technology company, today announced that Japan’s Ministry of Health, Labour and Welfare has approved the Company’s Perceval® sutureless aortic heart valve to treat aortic valve disease.
“With this approval for Perceval, an innovative and trusted valve platform, we are able to provide patients and clinicians in Japan with a new option for aortic heart valve replacement,” said Noriaki Kawana, President, LivaNova Japan.
The Perceval sutureless valve is supported by a strong body of evidence with more than 10 years of clinical experience. The valve is specifically designed to reduce the physiological impact of aortic valve replacement and improve patient outcomes. Perceval is also designed to be highly versatile and suitable for a wide range of surgical approaches, including traditional and minimally invasive.
“At LivaNova, we are committed to enhancing patient care around the world, and will continue to address the increasing global need for advanced aortic valve solutions,” said Roy Khoury, President, LivaNova International.
LivaNova obtained CE Mark for Perceval in 2011 and U.S. Food and Drug Administration approval in 2016. To date, more than 25,000 patients worldwide have been treated with the Perceval valve.