Edwards KONECT RESILIA Aortic Valved Conduit, MITRIS RESILIA Mitral Valve Receive Health Canada Approval

MISSISSAUGA, ON, July 29, 2021 /CNW/ -- Edwards Lifesciences (Canada) Inc. has announced it 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, M.D., Chair/Chief of Cardiac Surgery, London Health Sciences Centre and Western University.  "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 4-7 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."

About the KONECT RESILIA Aortic Valved Conduit

The KONECT RESILIA aortic valved conduit (AVC), is the first ready-to-implant solution for bio-Bentall procedures, a complex surgery that involves replacement of a patient's aortic valve, aortic root and the ascending aorta. The KONECT device also incorporates the advanced RESILIA tissue, which allows devices to be stored under dry packaging conditions, facilitating ease of use during patient care.

About the MITRIS RESILIA Mitral Valve

The MITRIS RESILIA valve offers multiple meaningful advancements for both surgeons and patients. Most importantly, this valve features the incorporation of RESILIA tissue, the latest advancement in tissue innovation from Edwards. The MITRIS RESILIA valve also incorporates features that enhance patient lifetime management: excellent visibility under fluoroscopy to facilitate potential future transcatheter interventions and low-profile stents that minimize protrusion into the left ventricular outflow tract.  The MITRIS RESILIA valve is built on the trusted Carpentier-Edwards PERIMOUNT platform, which in 2021, celebrates 40 years of innovative valve replacements for patients.

About Edwards Lifesciences

Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com and follow us on Facebook, Instagram, LinkedIn, Twitter and YouTube.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements made by Dr. Chu and Ms. Ryan and statements regarding expected product benefits, patient outcomes, future plans related to the product lines, objectives and expectations and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company's filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2020, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2021. These filings, along with important safety information about our products, may be found at Edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, INSPIRIS, INSPIRIS RESILIA, KONECT, KONECT RESILIA, MITRIS, MITRIS RESILIA, PERIMOUNT, and RESILIA are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. This statement is made on behalf of Edwards Lifesciences Corporation and its subsidiaries.

SOURCE Edwards Lifesciences (Canada) Inc.