Sustainability report

Product design & innovation

At Edwards, we constantly innovate to better meet the needs of patients with cardiovascular disease. Our focus on innovation allows us to develop life-saving products and therapies that transform the lives of patients around the world.

Definition

Designing products to better meet the needs of patients; investing in research and development; and employing innovative methods and solutions to improve design and performance of products.

Our aspirations

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Transforming patient lives with breakthrough medical technologies

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Passionate engagement that strengthens our communities

Material topics
Highlight story

Edwards Receives Approval for SAPIEN 3 with Alterra Prestent for Transcatheter Pulmonic Valve Replacement

In December 2021, Edwards received approval from the U.S. Food and Drug Administration (FDA) for the use of the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent (SAPIEN 3 with Alterra) for patients with severe pulmonary regurgitation.

The Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) system combines the proven SAPIEN 3 transcatheter heart valve and the Alterra adaptive prestent to expand transcatheter therapy options for congenital heart valve disease patients. The Alterra prestent compensates for variations in size and morphology of the right ventricular outflow tract to provide a stable landing zone for the SAPIEN 3 valve.

"The FDA approval of the SAPIEN 3 with Alterra is great news for patients around the world, many of whom have endured numerous surgical procedures to treat their congenital heart disease," said Dr. Evan Zahn, M.D., Director of Guerin Family Congenital Heart Program at the Smidt Heart Institute, Cedars-Sinai Medical Center, and principal investigator for the ALTERRA clinical trial. "The outstanding outcomes achieved by SAPIEN 3 with Alterra will expand the range of patients who require pulmonary valve replacement that we can now treat with minimally invasive therapy. This will result in significant improvements in quality of life and a reduction in the number of surgeries and procedures that a congenital heart patient requires over the course of their lifetime."

While pulmonic heart valve replacements represent a small fraction of the heart valve replacements done each year, it is generally required to replace valves in adolescent and adult patients suffering from Tetralogy of Fallot or other congenital heart valve defects. "Many of these patients endure repeated open-heart surgeries to address heart conditions present since birth, which takes a huge toll on their ability to lead normal lives. The SAPIEN 3 with Alterra provides a new treatment option that can reduce the number of invasive procedures these patients face in their lifetimes," said Larry Wood, corporate vice president, transcatheter aortic valve replacement.

Entire press release available in our online Newsroom.

Highlight story

Edwards Receives Clearance for Hypotension Prediction Index Software for Noninvasive Acumen IQ Cuff

In June 2021, Edwards received U.S. Food and Drug Administration clearance of its Acumen Hypotension Prediction Index (HPI) software with the Acumen IQ finger cuff. This is the first noninvasive solution that unlocks Acumen HPI software and uses machine learning to alert clinicians of the likelihood a patient is trending toward hypotension, or low blood pressure. Until now, Acumen HPI software has only been available for patients using an invasive arterial line.

"Numerous studies, including our research, have demonstrated an association between intraoperative hypotension and increased risk of acute kidney injury, myocardial injury and even death," said Kamal Maheshwari, M.D., MPH, anesthesiologist from Cleveland Clinic Foundation. "The noninvasive Acumen IQ cuff provides the opportunity to reduce hypotension in a broader range of patients, including those who do not require an invasive arterial line. The cuff, along with the predictive capabilities of Acumen HPI software to proactively manage hypotension, will have a meaningful impact on patients."

In addition to unlocking predictive capabilities, Acumen IQ cuff provides access to automatically calculated, beat-to-beat hemodynamic parameters including mean arterial pressure and cardiac output.

"This latest predictive technology demonstrates our commitment to patient care and providing clinicians with 'smart' monitoring tools that allow for better prediction and management," said Katie Szyman, Edwards' corporate vice president, critical care.

For more information, please see the related press release.

These highlight stories and referenced news releases include 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 Mr. Wood and statements regarding expected product benefits, patient outcomes, post-treatment reduction of invasive procedures, objectives and expectations and other statements that are not historical facts; and 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, Alterra, Carpentier-Edwards, Carpentier-Edwards PERIMOUNT, Edwards SAPIEN, Edwards SAPIEN 3, MITRIS, MITRIS RESILIA, PERIMOUNT, RESILIA, SAPIEN and SAPIEN 3 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.