CLASP IID ONE-YEAR DATA CONFIRM SAFETY AND EFFICACY OF EDWARDS PASCAL SYSTEM FOR DEGENERATIVE MITRAL REGURGITATION

Rhea-AI Summary

Edwards Lifesciences announces positive one-year results from CLASP IID trial and registry, confirming benefits of PASCAL system for mitral regurgitation reduction.

Positive

• The CLASP IID trial and registry showed that the PASCAL system achieved a freedom from major adverse events rate of 84.7% at one year. 95.8% of patients achieved MR ≤2+ at one year. 77.1% of PASCAL patients in the trial achieved a MR rate of ≤1+. The PASCAL system also showed sustained outcomes of high survival, low heart failure hospitalization, and meaningful quality-of-life improvements.

Negative

• None.

SAN FRANCISCO, Oct. 26, 2023 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW) announced one-year results from CLASP IID, the first randomized controlled trial that directly compares two contemporary mitral transcatheter edge-to-edge repair (TEER) therapies, as well as one-year results from the CLASP IID registry. The studies confirm the clinical and quality-of-life benefits of mitral regurgitation (MR) reduction with the PASCAL system in a broad population of patients with degenerative mitral regurgitation (DMR). Results from the CLASP IID randomized trial and registry 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, and simultaneously published in JACC: Cardiovascular Interventions. 

Patients enrolled in the CLASP IID pivotal trial had significant symptomatic DMR and were determined to be at prohibitive surgical risk. Patients enrolled in the CLASP IID registry met those same criteria yet were deemed ineligible for randomization. One-year results from the CLASP IID randomized trial showed the PASCAL system achieved:

• Freedom from major adverse events rate of 84.7 percent at one year, and
• Significant and sustained MR reduction, with 95.8 percent of patients achieving MR ≤2+ at one year.

Increasingly, the MR reduction goal with TEER is to achieve MR ≤1+ because contemporary evidence suggests reduced regurgitation may correlate with improved long-term patient outcomes. At one year, 77.1 percent of PASCAL patients in the trial achieved a MR rate of ≤1+. The PASCAL system also showed sustained outcomes of high survival, low heart failure hospitalization and meaningful quality-of-life improvements.

"These data from the CLASP IID randomized trial and registry further advance mitral edge-to-edge repair as an important treatment option for a wide range of very sick patients who suffer with debilitating symptoms," said Firas Zahr, MD, director of Interventional Cardiology and co-director of the Complex Heart Valve Program at Oregon Health & Science University and CLASP IID Study Investigator. "Patients receiving the PASCAL system experienced significant improvements in functional capacity and quality of life that were sustained for one year."

The CLASP IID trial is a prospective randomized controlled trial comparing the safety and effectiveness of the PASCAL system to the MitraClip system. Results were reported on 300 patients with 2:1 randomization (204 PASCAL / 96 MitraClip), with clinical events committee and echo core lab adjudication. The CLASP IID registry enrolled 98 patients. The trial and registry included 57 sites in the US, Canada and Europe, with most clinical operators new to using the PASCAL system and all having experience with the MitraClip system.

"We are pleased that these one-year results affirm the safety and effectiveness of the PASCAL system and the benefits of TEER for this undertreated patient population," said Daveen Chopra, Edwards' corporate vice president, transcatheter mitral and tricuspid therapies. "Growing our body of clinical evidence in support of our patient-driven therapies is a high priority at Edwards, and we are committed to pursuing multiple pivotal trials in our efforts to transform treatment for a broad population of patients in need."

As part of Edwards' continued commitment to building robust real-world evidence, patients receiving the PASCAL Precision system in the US are enrolled in a post-market registry for five years. Additional ongoing studies of the PASCAL system include the single-arm CLASP trial and European post-market MiCLASP registry. The PASCAL Precision system is one of multiple transcatheter repair or replacement therapies in development by Edwards and is approved for degenerative mitral regurgitation in the US and Japan and has CE Mark for the treatment of mitral degenerative and functional regurgitation, and tricuspid regurgitation.

About TEER
Transcatheter Edge-to-Edge Repair (TEER) of the mitral valve is used in the treatment of MR. TEER approximates the anterior and posterior mitral valve leaflets by grasping them with a clasping device in an approach similar to a treatment developed in cardiac surgery called the Alfieri stitch.

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, CLASP, Edwards PASCAL, Edwards PASCAL Precision, MiCLASP, 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

FAQ

What are the one-year results from the CLASP IID trial and registry?

The one-year results from the CLASP IID trial and registry showed that the PASCAL system achieved a freedom from major adverse events rate of 84.7% at one year and 95.8% of patients achieved MR ≤2+ at one year. 77.1% of PASCAL patients in the trial achieved a MR rate of ≤1+. The PASCAL system also showed sustained outcomes of high survival, low heart failure hospitalization, and meaningful quality-of-life improvements.

What is the PASCAL system?

The PASCAL system is a transcatheter edge-to-edge repair (TEER) therapy used for mitral regurgitation reduction.

What were the criteria for enrollment in the CLASP IID trial and registry?

Patients enrolled in the CLASP IID pivotal trial had significant symptomatic degenerative mitral regurgitation (DMR) and were determined to be at prohibitive surgical risk. Patients enrolled in the CLASP IID registry met the same criteria but were deemed ineligible for randomization.

What other studies and registries are ongoing for the PASCAL system?

Other ongoing studies of the PASCAL system include the single-arm CLASP trial and European post-market MiCLASP registry. Patients receiving the PASCAL Precision system in the US are also enrolled in a post-market registry for five years.

What is Edwards Lifesciences' commitment regarding clinical evidence?

Edwards Lifesciences is committed to building robust real-world evidence and pursuing multiple pivotal trials to transform treatment for a broad population of patients in need.