Clinical Data Updates On Edwards' Transcatheter Mitral, Tricuspid Programs Presented At EuroPCR

Rhea-AI Summary

Edwards Lifesciences (NYSE: EW) announced positive clinical outcomes from its transcatheter mitral and tricuspid valve programs presented at EuroPCR 2021. Key findings include:

• TRISCEND study: 30-day results showed device success of 98% and significant TR reduction.
• CLASP study: 2-year survival rate at 80% with an 85% reduction in heart failure hospitalizations.
• CLASP TR study: 6-months data indicated substantial safety and TR reduction.
• TriBAND study: 30-day outcomes revealed a device success rate of 97% with low mortality at 1.6%.

Both the PASCAL and Cardioband systems hold CE Mark in Europe but are not yet approved in the U.S.

Positive

• TRISCEND study showed 30-day device success rate of 98% and significant improvement in TR severity.
• CLASP study demonstrated sustained 2-year survival rate of 80% and 85% reduction in heart failure hospitalizations.
• CLASP TR study reported 6-month safety and significant TR reduction, with 78% of patients having mild TR.
• TriBAND study indicated a device success rate of 97% and low all-cause mortality of 1.6% at 30 days.

Negative

• PASCAL and Cardioband systems are not approved in the U.S., limiting market reach.

IRVINE, Calif., May 18, 2021 /PRNewswire/ -- Edwards Lifesciences (NYSE: EW) today announced that clinical results from the company's transcatheter mitral and tricuspid programs were presented as part of the late-breaking clinical trials at EuroPCR 2021, demonstrating positive outcomes for patients impacted by mitral or tricuspid heart valve disease.

The clinical data presentations provided the following updates:

• The 30-day outcomes from the TRISCEND study of the transfemoral EVOQUE tricuspid valve replacement system demonstrated technical feasibility and an acceptable safety profile, along with improvements in tricuspid regurgitation (TR) and symptoms in patients with clinically significant TR. The favorable 30-day results showed high device and procedural success rates of 98% and 94%, respectively, and significant reduction in TR severity, with 98% of patients experiencing mild or less.
• Two-year outcomes from the CLASP study of the PASCAL system for mitral valve repair demonstrated a sustained high rate of survival at 80%, as well as 87% clinical events committee (CEC) adjudicated freedom from heart failure rehospitalization and an 85% reduction in annualized heart failure hospitalization rates. Patients enrolled in the CLASP study had symptomatic, clinically significant mitral regurgitation (MR) despite optimal medical therapy. Patients treated with the PASCAL system also experienced durable MR reduction, with evidence of left ventricular reverse remodeling. At two years, 78% of patients had mild (1+) or none/trace MR and 97 percent had ≤2+ MR, with echo core lab adjudication.
• The 6-month outcomes from the CLASP TR early feasibility study of the PASCAL system for tricuspid valve repair demonstrated favorable safety and significant TR reduction. The results showed high implant, procedural and clinical success rates, while also demonstrating low complication rates. Patients enrolled in the CLASP TR study had symptomatic severe TR, and, at six months after treatment, 78% of patients had mild or moderate TR. In addition to the clinical improvements, patients also experienced positive functional and quality of life outcomes, which were sustained at 6 months.
• Results at 30 days from the TriBAND post-market clinical follow-up study of the Cardioband tricuspid valve reconstruction system demonstrated high device success of 97%, and low all-cause mortality of 1.6%. Patients in the study had chronic symptomatic TR, and 94% of patients had severe or greater TR at baseline. Data from 30 days after treatment with the Cardioband system showed that 85% of patients experienced at least one grade reduction of significant TR, as well as improvements in functional status and quality of life measures.

"In addition to the positive clinical outcomes the patients treated in these studies experienced, it was also encouraging to see improvements in functional status and quality of life," said Bernard J. Zovighian, Edwards' corporate vice president, transcatheter mitral and tricuspid therapies. "The patient populations impacted by mitral and tricuspid valve disease are large, diverse and complex. As we pursue our focus to lead and transform their treatment, the results from clinical studies that span our differentiated portfolio of therapies are important contributors to building the evidence to support these transformative transcatheter mitral and tricuspid treatments in different types of patients."

The PASCAL system and Cardioband system received CE Mark for treatment of patients with both mitral and tricuspid valve disease, and both therapies are available commercially in Europe; neither are approved in the United States and are only available via clinical trials.

The EVOQUE valve replacement system is an investigational device and is not available for sale in any country.

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 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, statements made by Mr. Zovighian and statements regarding expected product benefits, patient outcomes, 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 the Quarterly Report on Form 10-Q for the quarter ended March 31, 2021. These filings, along with important safety information about our products, may be found at edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, Cardioband, Edwards PASCAL, EVOQUE, PASCAL and TRISCEND are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. This statement is made on behalf of Edwards Lifesciences Corporation and its subsidiaries.

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SOURCE Edwards Lifesciences Corporation

FAQ

What were the outcomes of the TRISCEND study presented by Edwards Lifesciences?

The TRISCEND study reported a 30-day device success rate of 98% and significant improvements in tricuspid regurgitation severity.

What does the CLASP study indicate about the PASCAL system?

The CLASP study showed a 2-year survival rate of 80% and an 85% reduction in heart failure hospitalizations.

What are the 6-month results from the CLASP TR early feasibility study?

The 6-month results indicated favorable safety and significant TR reduction, with 78% of patients experiencing mild or moderate TR.

What is the CE Mark status of Edwards Lifesciences' devices?

The PASCAL and Cardioband systems have received CE Mark for use in Europe but are not approved in the United States.