Edwards Lifesciences (NYSE: EW) announced today at Cardiovascular Research Technologies (CRT) 2024 the compelling results from two large, real-world studies based on TVT Registry data that demonstrated continued excellent outcomes for patients treated with the Edwards SAPIEN valve platform.

A study of Edwards’ latest TAVR technology, the SAPIEN 3 Ultra RESILIA valve, found lower rates of paravalvular leak (PVL) at 30 days, lower echo-derived gradients and larger effective orifice areas across all valve sizes when compared to the SAPIEN 3 and SAPIEN 3 Ultra valves. These data were presented yesterday during a podium presentation and simultaneously published in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions. In a second study presented during the late-breaking clinical trials session, small Edwards SAPIEN TAVR valves demonstrated equally excellent outcomes at 3 years as compared to larger SAPIEN TAVR valve sizes.

“These real-world data further add to the robust body of evidence on the performance of Edwards SAPIEN TAVR and highlight the meaningful advancements of the SAPIEN 3 Ultra RESILIA valve, which provides patients with severe aortic stenosis the leading option for true lifetime management of their heart valve disease,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart.

Real-World Results of the SAPIEN 3 Ultra RESILIA Valve

In a study of real-world evidence of patients from the TVT Registry, researchers compared the outcomes of more than 10,000 patients across more than 800 sites in the United States treated with the SAPIEN 3 Ultra RESILIA valve to those receiving SAPIEN 3 Ultra and SAPIEN 3 valves using procedural and hemodynamic data and clinical outcomes for propensity-matched cohorts.

The study found that all Edwards TAVR platforms demonstrated excellent PVL results. Notably, there was a statistically significant reduction in PVL for the 29 mm SAPIEN 3 Ultra RESILIA valve as compared to the 29 mm SAPIEN 3, with 88.3% of patients exhibiting no PVL and only 10.7% of patients exhibiting mild PVL. The SAPIEN 3 Ultra RESILIA valve was also associated with significantly lower echocardiography-derived mean gradients and larger effective orifice areas across all four valve sizes with low rates of all-cause mortality, cardiac death, all stroke, life-threatening bleeding, major vascular complications, and permanent pacemaker implantation in-hospital or at 30 days.

Late-Breaking Clinical Results Comparing Small Edwards TAVR Valves to Larger Valves

An analysis of 8,100 propensity matched patients across more than 800 sites in the United States found that patients treated with a 20mm Edwards SAPIEN valve demonstrated excellent all-cause mortality and stroke outcomes at 3-years, equivalent to those receiving 23, 26 and 29mm SAPIEN valve sizes. Among mortality indicators, researchers concluded that while PVL and new permanent pacemaker implantation were both associated with increased mortality, the relationship between post-procedural echo-derived mean gradients and clinical outcomes is nonlinear and more complex.

“This examination of these real-world data gives us important insights into the actual performance of small Edwards valves and reaffirms the excellent outcomes for patients receiving SAPIEN TAVR, regardless of valve size,” said Amr Abbas, MD, Professor of Medicine at Oakland University William Beaumont School of Medicine, Director of Structural Heart at Corewell Health East, William Beaumont University Hospital and principal investigator in the small SAPIEN valve study.

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, post-treatment reduction of invasive procedures, 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. 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, Edwards SAPIEN 3 Ultra, RESILIA, SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

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