TAVR with SAPIEN 3 Demonstrated as Economically Dominant Treatment Strategy Compared to Surgery in Partner 3 Analysis

IRVINE, Calif., Nov. 5, 2021 /PRNewswire/ -- Edwards Lifesciences (NYSE: EW) today announced that a cost-effectiveness analysis comparing transcatheter aortic valve replacement (TAVR) to surgery demonstrated that TAVR with SAPIEN 3 is an economically dominant treatment strategy, offering improved outcomes and reduced cost. This analysis from the PARTNER 3 trial was presented during the late-breaking clinical trials at the 33rd Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.

The study compared healthcare costs, life expectancy and quality-adjusted life expectancy for patients with severe aortic stenosis at low risk for surgery, who were treated with TAVR or surgery in the PARTNER 3 trial.

A formal cost-effectiveness analysis conducted for the study found:

• TAVR using the SAPIEN 3 valve resulted in cost savings of greater than $2,000 per patient through the 2-year study period. This was achieved through marked reductions in hospital length of stay and substantially lower follow-up costs, which overcame higher index hospitalization and procedural costs for TAVR.
• Over the 2-year follow-up period, TAVR also led to a small but significant improvement in quality-adjusted life expectancy, driven by improved early quality of life and also survival.
• The probability that TAVR is highly cost-effective versus SAVR is approximately 95%.

"In addition to the outstanding clinical results compared with surgery, the finding that TAVR with SAPIEN 3 is also a lower cost strategy for low-risk patients empowers both cardiologists and patients with real choice in determining the right treatment option for severe aortic stenosis," said David J. Cohen, MD, MSc, Director of Clinical and Outcomes Research at the Cardiovascular Research Foundation and Director of Academic Affairs at St. Francis Hospital in New York. "TAVR is a unique technology with advantages over surgery from the perspective of both the patient and the healthcare system."

The PARTNER 3 trial randomized 1,000 patients at 71 centers between March 2016 and October 2017. Patients were assigned to undergo either TAVR with the SAPIEN 3 valve or surgery with any commercially available surgical valve. Clinical results from the PARTNER 3 trial were presented in 2019 and published in The New England Journal of Medicine.

"As we celebrate the 10-year anniversary of the SAPIEN valves' FDA approval in the United States, it is inspiring to reflect on the impact this technology has had on the treatment of patients with severe aortic stenosis," said Larry Wood, Edwards' corporate vice president, transcatheter aortic valve replacement. "These data add to the substantial body of evidence showing the advantages of TAVR over surgery in terms of effectiveness and cost efficiency at all surgery risk levels. We are proud that SAPIEN TAVR continues to stand out as a unique technology that extends patients' lives, improves quality of life and saves money for the healthcare system."  

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 Mr. Wood and statements regarding expected product benefits, patient outcomes, product impacts to the healthcare system, 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 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 quarters ended March 31, 2021, and June 30, 2021. These filings, along with important safety information about our products, may be found at Edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, PARTNER, PARTNER 3, SAPIEN and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

SOURCE Edwards Lifesciences Corporation

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