TRISCEND II SIX-MONTH DATA FOR FIRST 150 PATIENTS SUCCESSFULLY DEMONSTRATE SAFETY AND EFFICACY OF EDWARDS EVOQUE SYSTEM FOR SEVERE TRICUSPID REGURGITATION

Rhea-AI Summary

Edwards Lifesciences announces successful results from TRISCEND II trial for EVOQUE tricuspid valve replacement system

Positive

• TRISCEND II trial achieves primary safety endpoint at 30 days and both co-primary effectiveness endpoints at six months, demonstrating superiority to OMT alone
• EVOQUE valve successfully implanted in 95.8% of patients
• Major adverse event rate at 27.4% at 30 days
• 98.8% of patients achieved ≤ moderate TR and 93.8% achieved ≤ mild TR at six months
• Superior quality-of-life and functional outcomes at six months for the EVOQUE system plus OMT over OMT alone

Negative

• None.

SAN FRANCISCO, Oct. 26, 2023 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW) today announced successful results from TRISCEND II, a randomized controlled pivotal trial designed to evaluate the safety and effectiveness of the groundbreaking EVOQUE tricuspid valve replacement system with optimal medical therapy (OMT) compared to OMT alone with 2:1 randomization.

The outcomes for the first 150 patients of the TRISCEND II trial achieved the primary safety endpoint at 30 days and both co-primary effectiveness endpoints at six months, demonstrating superiority to OMT alone. Results from the TRISCEND II trial were presented as a late-breaking clinical trial session at the 35^th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation. 

Patients enrolled in the TRISCEND II trial had at least severe tricuspid regurgitation (TR).  The EVOQUE valve was successfully implanted in 95.8 percent of patients and the trial met all primary endpoints with:

• Major adverse event rate at 27.4 percent at 30 days;
• Significant TR grade reduction with 98.8 percent of patients achieving ≤ moderate TR and 93.8 percent achieving ≤ mild TR at six months; and
• Substantially superior quality-of-life and functional outcomes at six months for the composite endpoint including KCCQ, NYHA and 6MWD for the EVOQUE system plus OMT over OMT alone.

"We are excited by the safety and effectiveness data from the first 150 patients of the TRISCEND II pivotal trial," said Susheel Kodali, MD, director, Structural Heart and Valve Center at Columbia University Irving Medical Center/New York-Presbyterian Hospital and TRISCEND II Study Principal Investigator. "With no predicate study of a novel transcatheter tricuspid valve replacement, these data and outcomes give us great hope in the EVOQUE system as an option to treat patients who are very sick and have few effective therapeutic options."

An FDA Advisory Committee Meeting of the EVOQUE system is expected in Jan. 2024, followed by an anticipated US approval in mid-2024. In 2019, the EVOQUE system received FDA Breakthrough Designation, which is designed to provide patients with timely access to new devices for life-threatening or irreversibly debilitating conditions. As a result, the TRISCEND II trial was specifically designed to include a pre-specified analysis of the first 150 patients enrolled to evaluate the safety and effectiveness of the EVOQUE system. The full cohort of 400 patients is enrolled. Earlier this month, the EVOQUE system received CE Mark for the transcatheter treatment of eligible patients with TR.

"Patients suffering from severe tricuspid regurgitation endure debilitating symptoms and poor quality of life and are desperate for effective treatment, as evidenced by the rapid enrollment in this trial," said Daveen Chopra, Edwards' corporate vice president, transcatheter mitral and tricuspid therapies. "These data build upon the promising foundation of results previously published from the single-arm TRISCEND study and add to our growing body of contemporary clinical evidence that enables more patients in need to receive treatment."

Edwards is committed to transforming the treatment of patients with mitral and tricuspid valve disease, supported by robust clinical evidence. The EVOQUE system is one of multiple transcatheter repair or replacement therapies in development by Edwards.

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. Chopra 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, 2022, and its Quarterly Reports on Form 10-Q for the quarters ended March 31 and June 30, 2023. These filings, along with important safety information about our products, may be found at Edwards.com.

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

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SOURCE Edwards Lifesciences Corporation

FAQ

What are the results of the TRISCEND II trial for the EVOQUE tricuspid valve replacement system?

The trial achieved the primary safety endpoint at 30 days and both co-primary effectiveness endpoints at six months, demonstrating superiority to OMT alone. 95.8% of patients had a successful implantation of the EVOQUE valve. The major adverse event rate at 30 days was 27.4%. 98.8% of patients achieved ≤ moderate TR and 93.8% achieved ≤ mild TR at six months. The EVOQUE system plus OMT showed superior quality-of-life and functional outcomes at six months compared to OMT alone.

When is the FDA Advisory Committee Meeting for the EVOQUE system expected?

The FDA Advisory Committee Meeting is expected in Jan. 2024.

When is the anticipated US approval for the EVOQUE system?

The anticipated US approval is expected in mid-2024.

What designation did the EVOQUE system receive from the FDA in 2019?

The EVOQUE system received FDA Breakthrough Designation in 2019.

What is the purpose of the TRISCEND II trial?

The TRISCEND II trial is designed to evaluate the safety and effectiveness of the EVOQUE system for transcatheter tricuspid valve replacement.