2022-09-17 | NYSE:EW | Press release

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BOSTON, September 17, 2022 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW) announced the results of CLASP IID, the first randomized controlled trial that directly compares two contemporary transcatheter edge-to-edge repair (TEER) therapies. The study confirms that TEER is a safe and effective therapy in patients with degenerative mitral regurgitation (DMR). Results from the pivotal CLASP IID trial were presented at a late-breaking clinical science session at the 34e Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, and published concurrently in JACC: Cardiovascular Interventions.

Patients enrolled in the pivotal CLASP IID trial had severe symptomatic DMR and were deemed to be at prohibitive surgical risk. The CLASP IID trial met its primary endpoints for safety and efficacy, with the PASCAL system demonstrating non-inferiority in safety and efficacy to the MitraClip device. The PASCAL device showed:

  • Low composite major adverse event rate of 3.4% at 30 days, and
  • Significant and durable reduction in MR with 97.7% of patients achieving MR ≤ 2+ at six months.

The PASCAL system further demonstrated a significant and sustained MR ≤1+ with 83.7% of patients having an MR ≤1+ at six months. Results from the PASCAL System also showed favorable ventricular remodeling with improved stroke volume, and patients receiving the PASCAL System experienced significant improvements in functional capacity and quality of life.

“The randomized CLASP IID trial further establishes the PASCAL System as a safe and effective therapy, expanding the arsenal of catheter-based mitral valve treatment options for patients with MRD,” said Scott LimMD, Director, Advanced Heart Valve Center at University of Virginia Principal investigator of the health system and the CLASP IID study. “Several distinct design features of the PASCAL system, including the flexible nitinol design and the ability to stretch, contribute to the positive results of this study.”

The CLASP IID trial is a prospective randomized controlled trial comparing the safety and efficacy of the PASCAL System to the MitraClip System. Results were reported on 180 patients with a 2:1 randomization (117 PASCAL/63 MitraClip), with echo core laboratory decision. The trial included 43 sites in the United States, Canada and Europewith most clinical operators new to the use of the PASCAL system and all having experience with the MitraClip system.

“As we consider the many patients with DMR who suffer from debilitating symptoms and who could benefit from a TEER procedure, we are very pleased with the results of the CLASP IID trial,” said Bernard J. Zovighian, Edwards vice president, transcatheter mitral and tricuspid therapies. “Edwards continues to prioritize generating evidence with world-class data in support of our patient-focused therapies, and we are proud to support this trial and many other pivotal trials as we work to transform treatment of those patients in need.”

Additional data presentations for the company at TCT 2022 include:

  • The PASCAL IID Registry: A Prospective Registry for Edge-to-Edge Transcatheter Repair in Prohibitively Risk Patients with Degenerative Mitral Regurgitation and Complex Mitral Valve Anatomy (September 17) – Last minute presenter: Jörg Hausleiter.
  • Deep dive session: mitral TEER = CLASP IID trials(September 17) – Moderators: Megan Coylewright, Linda D. Gillam. Speakers: Paul A. Grayburn, Konstantinos P. Koulogiannis, Raj Makkar, Jacob M. Mishell, Ralph Stephan von Bardeleben, Firas Zahr.
  • Frequency and Safety of Bioprosthetic Valve Fractures in Patients Undergoing Valve-in-Valve TAVR for Failing Surgical Valves Using SAPIEN 3/Ultra Valves: Insights from Real-World Data (September 18) – Presenter: Santiago Garcia.
  • Cardiac damage and quality of life after aortic valve replacement: results from the PARTNER trials (September 18) – Presenter: Philippe Genereux.

Edwards is committed to transforming the treatment of patients with structural heart disease, backed by strong clinical evidence. As part of Edwards’ ongoing commitment to building a body of evidence, patients receiving PASCAL Precision Therapy in the United States will be enrolled in the TVT Registry for five years. The PASCAL Precision System is one of multiple transcatheter repair or replacement therapies being developed by Edwards and the first transcatheter therapy approved for DMR in the United States. The PASCAL system received CE marking for the first time in Europe in 2019, and the PASCAL Precision system received CE marking in 2022.

About TEER

Transcatheter edge-to-edge repair (TEER) of the mitral valve is used in the treatment of mitral regurgitation. TEER brings the anterior and posterior mitral valve leaflets together by grasping them with a clipping device in an approach similar to a treatment developed in heart surgery called the Alfieri stitch.

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 and June 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, Edwards PASCAL, Edwards PASCAL Precision, PASCAL and PASCAL Precision are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

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SOURCE Edwards Lifesciences Corporation

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