Edwards Lifesciences has announced that it has received regulatory approval from Health Canada for both the Konect Resilia aortic valved conduit and the Mitris Resilia mitral valve. Both feature the company’s novel Resilia tissue platform with anti-calcification properties currently used on the Inspiris Resilia aortic valve.
“Innovation is paramount to the future of cardiac surgery,” said Michael Chu, chair/chief of Cardiac Surgery, London Health Sciences Centre and Western University, London, Canada. “Edwards continues to invest in new technology for surgeons and our patients. The addition of the Konect Resilia aortic valved conduit and the Mitris Resilia valve offers important new solutions for patients impacted by heart valve disease.”
Resilia tissue is bovine pericardial tissue transformed by an advanced integrity preservation technology, and serves as the platform for Edwards’ new class of resilient valves. It has been studied in two clinical trials related to treatment of the aortic and mitral valves, which together represent outcomes on more than 900 patients and more than 3,500 patient years of follow-up. The patient follow-up period for the studies is, at this time, in the range of four to seven years.
“Collaborating with surgeons from around the world, Edwards is dedicated to developing patient-centric innovations that improve long-term care and outcomes for cardiac surgery patients,” said Sharon Ryan, Edwards’ managing director, Canada. “Canada is the first country to have regulatory approval for all three Edwards Resilia tissue products. We are excited to bring these innovations to centres across the country and to continue to support best clinical outcomes.”