LONDON, November 27, 2022 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW) announced that the one-year results of patients treated in the prospective, global, multicenter, single-arm TRISCEND study of the Transcatheter Tricuspid Valve Replacement System The company’s EVOQUE demonstrated favorable safety, efficacy and quality of life results. The data was presented during the last minute testing session at PCR London Valves 2022.
Patients included in the TRISCEND study presented with moderate or more functional or degenerative symptomatic tricuspid regurgitation (TR), despite optimal medical treatment. The TRISCEND study enrolled 176 patients, representing the largest data set among transcatheter tricuspid valve replacement therapies.
After positive results at 30 days and 6 months, results at one year demonstrated:
- High survival of 90.1% and high absence of hospitalization for heart failure at 88.4%;
- Significant and sustained reduction in TR, with 97.6% of patients with mild or trace TR (n=84);
- Significant improvement in functional outcomes and quality of life, with 93% of patients in NYHA class I or II versus 26% at baseline (n=89) and a 26-point increase in KCCQ score from baseline (n = 102).
“Tricuspid regurgitation is widespread, 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 a transcatheter valve replacement treatment option. approved,” said Professor Didier Tchetche, Physician, Clinique Pasteur, Toulouse, France and co-principal investigator of the TRISCEND study. “The one-year results for patients who received EVOQUE tricuspid valve replacement in the TRISCEND study provide strong support for our confidence in this therapy as an option for patients with tricuspid regurgitation. “
“We are encouraged by the sustained safety and performance results demonstrated by the EVOQUE System after one year, as it represents a significant therapy in our portfolio of transcatheter therapies under development to help improve the quality of life of patients. with tricuspid and mitral valve diseases,” said Bernard J. Zovighian, Edwards vice president, transcatheter mitral and tricuspid therapies. “Edwards’ eight data presentations included in this year’s London Valves PCR program demonstrate our long-term investment in innovation and the generation of clinical evidence to meet patient needs and mark a new era for our company.
Additional presentations under the London Valves PCR Program 2022 for Edwards’ mitral and tricuspid transcatheter therapy portfolio include:
- Transcatheter Tricuspid Valve Repair: The CLASP II TR Clinical Trial Cohort (November 27)
- Last Minute Essay Presenter: Michael Young
- Transcatheter Tricuspid Annular Reduction: One-Year Results from the TriBAND Study (November 27)
- Last Minute Essay Presenter: Volker Rudolf
- The CLASP IID Trial: A Randomized Comparison of Edge-to-Edge Transcatheter Repair Devices for Degenerative Mitral Regurgitation in Patients at Prohibitive Surgical Risk (November 28)
- Presenter of the last minute essay: Jörg Hausleiter
- The CLASP IID Registry: A Prospective Registry for Edge-to-Edge Transcatheter Repair in Patients with Anatomically Complex Degenerative Mitral Insufficiency (November 28)
- Presenter: Jörg Hausleiter
- Three-year results of transcatheter mitral repair from the CLASP study (November 28)
- Presenter: Konstantinos Spargias
- One-year results of transcatheter mitral repair in the MiCLASP study (November 28)
- Transcatheter repair of tricuspid regurgitation: TriCLASP study, six-month follow-up (November 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 pivotal randomized trial is currently underway. The EVOQUE System is one of many transcatheter replacement or repair therapies being developed by Edwards as part of the company’s commitment to transform the treatment of patients with mitral and tricuspid valve disease, backed by strong evidence. contemporary clinics.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in patient-focused innovations for monitoring structural heart disease and critical care. 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 press release contains 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, goals and expectations and other statements that are not historical events. Forward-looking statements are based on estimates and assumptions made by the company’s management and are believed to be reasonable, although they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date they are made, and we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to place undue reliance on these forward-looking statements.
Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors detailed in the company’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and its Quarterly Reports on Form 10-Q for the quarters ended March 31 June 30thand September 30, 2022. These documents, along with important information about our product safety, can be found on 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.
SOURCE Edwards Lifesciences Corporation