MISSISSAUGA, Ontario, Jan. 25, 2018 /CNW/ -- Edwards Lifesciences Corporation, the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that Health Canada has approved its INSPIRIS RESILIA aortic valve, the first in a new class of resilient heart valves. The device is now commercially available.
"The INSPIRIS aortic valve provides patients, particularly those with active lifestyles, with a resilient tissue valve that is built on Edwards' legacy of excellence in heart valve innovations," said Francois Dagenais, M.D., chief of the division of cardiac surgery at Université Laval, which was the Canadian site that participated in the COMMENCE pivotal trial, a premarket approval study of the INSPIRIS RESILIA valve. "The INSPIRIS valve also incorporates new technology that complements the evolving transcatheter aortic valve replacement therapy, for possible future valve-in-valve replacement procedures for patients that may need future valve interventions."
The INSPIRIS valve features three differentiating elements:
- RESILIA tissue, a breakthrough tissue technology that delivers the combination of enhanced anti-calcification properties, improved sustained hemodynamic performance and dry storage;
- A first-of-its-kind expandable frame, VFit technology also incorporates fluoroscopically visible size markers and is designed for potential future valve-in-valve procedures;
- A trusted valve platform built on the proven performance of the Carpentier-Edwards PERIMOUNT valve design, which has more than 20 years of published clinical durability.
Approval of the INSPIRIS valve is supported by the COMMENCE pivotal trial. Published in the European Journal of Cardio-Thoracic Surgery, two-year data of 689 patients from the COMMENCE trial showed no cases of structural valve deterioration, valve thrombosis or nonstructural valve dysfunction. In addition, the European RESILIA tissue feasibility study, which initiated enrollment in 2011, underscores the safety and effectiveness of the RESILIA tissue. Four-year results from the European feasibility study were presented at the 31st European Association for Cardio-Thoracic Surgery's (EACTS) annual meeting in October.
About Edwards Lifesciences
Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. For more information, visit www.edwards.com and follow us on Twitter @EdwardsLifesci.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, statements by Dr. Dagenais and expectations regarding the product's potential benefits and risks, as well as expected future innovations. 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.
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, including but not limited to, unanticipated outcomes of expanded and longer term clinical experience with the product, or unanticipated manufacturing, quality, development or regulatory delays or issues. These and other additional factors are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2016. These filings, along with important safety information about our products, may be found at www.edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, COMMENCE, INSPIRIS, INSPIRIS RESILIA, PERIMOUNT, RESILIA, and VFit are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
SOURCE Edwards Lifesciences Corporation
For further information: Media, Sarah Huoh, +1-949-250-5070, or Investors, David K. Erickson, +1-949-250-6826, both of Edwards Lifesciences Corporation, http://www.edwards.com