EDWARDS LAUNCHES SAPIEN 3 ULTRA RESILIA VALVE FOLLOWING FDA APPROVAL

September 15, 2022

IRVINE, Calif., Sept. 12, 2022 /PRNewswire/ — Edwards Lifesciences ( NYSE: EW) today announced the launch of the SAPIEN 3 Ultra RESILIA valve, which incorporates Edwards’ breakthrough RESILIA tissue technology with the industry-leading SAPIEN 3 Ultra transcatheter aortic heart valve. The launch follows recent U.S. Food and Drug Administration (FDA) approval.

RESILIA tissue is a bovine pericardial tissue treated with advanced anti-calcification technology and serves as the platform for Edwards’ new class of valves, including the next generation SAPIEN X4 valve, which is currently undergoing clinical trials. RESILIA tissue delivers important advances to the SAPIEN 3 Ultra platform including enhanced calcium blocking properties and dry tissue packaging conditions that facilitate ease of use. RESILIA tissue has demonstrated freedom from structural valve deterioration at 5 years and provides the potential to extend the durability of the SAPIEN 3 Ultra RESILIA valve. It is used in the world’s leading surgical aortic valve, the Edwards INSPIRIS RESILIA valve.

“The SAPIEN 3 Ultra RESILIA valve builds on Edwards’ 40 years of leadership in tissue technology by combining advancements in tissue science with the industry leading SAPIEN 3 Ultra valve to offer the only dry storage transcatheter heart valve on the U.S. market today,” said Larry Wood, corporate vice president, transcatheter aortic valve replacement. “The RESILIA tissue’s anti-calcification technology addresses one of the primary causes of reintervention following heart valve replacement. The SAPIEN 3 Ultra RESILIA valve is a prime example of Edwards’ continued focus on innovating to meet the current and future needs of patients to help them live longer, healthier and more productive lives.”

The SAPIEN 3 Ultra RESILIA valve will be available in the U.S. in limited release in the fourth quarter of 2022. The commercial opportunity related to this approval is factored into 2022 financial expectations.

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, Edwards SAPIEN 3 Ultra RESILIA, Edwards INSPIRIS RESILIA, INSPIRIS RESILIA, INSPIRIS, RESILIA, SAPIEN, SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

SOURCE Edwards Lifesciences Corporation