Sustainability report

Product safety & quality

Edwards Lifesciences’ work to maintain product safety and quality supports our aspiration of excelling as a trusted partner through distinguished quality and integrity. Creating safe, quality products is the foundation of both our business success, our culture, and our purpose. Our reputation rests on delivering innovative, trustworthy products that save patient lives.

Definition

Monitoring, managing and reducing negative health and safety impacts of Edwards’ products. Maintenance of product quality and ensuring Edwards' products are free from any deficiencies or defects.

Our aspirations

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Excelling as a trusted partner through distinguished quality and integrity

Material topics
Highlight story

Edwards MITRIS RESILIA Valve Receives FDA Approval for Mitral Replacement Surgeries

In early 2022, Edwards Lifesciences received approval from the U.S. Food and Drug Administration (FDA) for the MITRIS RESILIA valve, a tissue valve replacement specifically designed for the heart's mitral position. This therapy is the company's latest innovation offering advanced RESILIA tissue with an anti-calcification technology that also allows devices to be stored under dry packaging conditions, facilitating ease of use.

RESILIA tissue is bovine pericardial tissue and serves as the platform for Edwards' new class of valves. "For patients who need mitral valve replacement, the advanced MITRIS RESILIA valve is based on a trusted pericardial valve platform, designed to mimic the native valve and incorporating tissue with integrity-preservation technology that will potentially allow the valve to last longer," said Kevin Accola, M.D., Cardiovascular Surgeon, AdventHealth Orlando.

Edwards is dedicated to partnering with clinicians to develop patient-centric innovations for complex surgical structural heart procedures that improve long-term care and outcomes for patients. The introduction of the MITRIS RESILIA valve completes the portfolio of surgical heart valve innovations incorporating the advanced RESILIA tissue, including an aortic valve, an aortic valved conduit and now a mitral valve.  Edwards continues to invest in innovations in the surgical structural heart field.

In addition to FDA approval, the MITRIS RESILIA valve has also received regulatory approval in Japan, Canada, and other countries globally.

For more information, please see the related press release and product page.

This highlight story and referenced 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. Accola and Mr. Chopra 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, 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, Carpentier-Edwards PERIMOUNT, 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.