Press releases

LONDON, Nov. 27, 2022 -- Edwards Lifesciences Corporation (NYSE: EW) announced that one-year results on patients treated in the single-arm, prospective, global, multi-center TRISCEND study of the company's EVOQUE transcatheter tricuspid valve replacement system demonstrated favorable safety, efficacy and quality-of-life outcomes. The data were presented during the late-breaking trials session at PCR London Valves 2022.

Patients enrolled in the TRISCEND study had symptomatic moderate or greater functional or degenerative tricuspid regurgitation (TR), despite optimal medical therapy. The TRISCEND study enrolled 176 patients, representing the largest dataset among transcatheter tricuspid valve replacement therapies.

Following positive 30-day and 6-month results, the one-year outcomes demonstrated:

• High survival of 90.1% and high freedom from heart failure hospitalization at 88.4%;
• Significant and sustained TR reduction, with 97.6% of patients with mild or trace TR (n=84);
• Significantly improved functional and quality-of-life outcomes, with 93% of patients in NYHA Class I or II compared to 26% at baseline (n=89) and a 26-point increase in KCCQ score over baseline (n=102).

"Tricuspid regurgitation is prevalent, undertreated and has a significant impact on patients' quality of life. With most TR patients at high risk for surgery, there is a great need for an approved transcatheter valve replacement treatment option," said Prof. Didier Tchetche, MD, Clinique Pasteur, Toulouse, France and TRISCEND study co-primary investigator. "The one-year results for patients who received the EVOQUE tricuspid valve replacement as part of the TRISCEND study provide important support for our confidence in this therapy as an option for patients who suffer from tricuspid regurgitation."

"We are encouraged by the sustained safety and performance outcomes demonstrated by the EVOQUE system at one year, as it represents a meaningful therapy in our portfolio of transcatheter therapies being developed to help improve the quality-of-life for patients with tricuspid and mitral valve diseases," said Bernard J. Zovighian, Edwards' corporate vice president, transcatheter mitral and tricuspid therapies. "Edwards' eight data presentations included in this year's PCR London Valves program deliver on our long-term investment in innovation and clinical evidence generation to meet the needs of patients and mark a new era for our company."

Additional presentations in the PCR London Valves 2022 program for Edwards' portfolio of transcatheter mitral and tricuspid therapies include:

• Transcatheter Tricuspid Valve Repair: The CLASP II TR Trial Roll-in Cohort (Nov. 27)
• Late-Breaking Trial Presenter: Michael Young
• Transcatheter Tricuspid Annular Reduction: The TriBAND Study 1 Year Outcomes (Nov. 27)
• Late-Breaking Trial Presenter: Volker Rudolph
• The CLASP IID Trial: A Randomized Comparison of Transcatheter Edge-to-Edge Repair Devices for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients (Nov. 28)
• Late-Breaking Trial Presenter: Jörg Hausleiter
• The CLASP IID Registry: A Prospective Registry for Transcatheter Edge-to-Edge Repair in Patients with Anatomically Complex Degenerative Mitral Regurgitation (Nov. 28)
• Presenter: Jörg Hausleiter
• Three-year Outcomes for Transcatheter Mitral Repair from the CLASP Study (Nov. 28)
• Presenter: Konstantinos Spargias
• One-year Outcomes for Transcatheter Mitral Repair from the MiCLASP Study (Nov. 28)
• Presenter: Philipp Lurz
• Transcatheter Repair of Tricuspid Regurgitation: TriCLASP Study Six-month Follow-up (Nov. 29)
• Presenter: Niklas Schofer

The EVOQUE valve replacement system is an investigational device and is not available for sale in any country. The TRISCEND II randomized pivotal trial is currently underway. The EVOQUE system is one of several transcatheter replacement or repair therapies in development by Edwards as part of the company's commitment to transform the treatment of patients with mitral and tricuspid valve disease, supported by robust contemporary clinical evidence.

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. Zovighian and statements regarding expected product benefits, patient outcomes, 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, 2021, and its Quarterly Reports on Form 10-Q for the quarters ended March 31, June 30, and September 30, 2022. These filings, along with important safety information about our products, may be found at Edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, CLASP, EVOQUE, MiCLASP, TriBAND, TriCLASP, and TRISCEND are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

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