Edwards' Pascal Precision System for TEER Studied at 6 Months in CLASP IID Trial

September 17, 2022—Edwards Lifesciences Corporation announced results from the prospective CLASP IID randomized controlled trial (RCT), which directly compared the safety and effectiveness of two contemporary transcatheter edge-to-edge repair (TEER) therapies: the Edwards Pascal Precision transcatheter valve repair system and the MitraClip system (Abbott).

According to Edwards, the study confirms TEER as a safe and effective therapy in patients with severe degenerative mitral regurgitation (DMR) at prohibitive surgical risk.

CLASP IID is the United States pivotal trial for the Pascal Precision device for TEER in patients with symptomatic DMR. On September 15, Edwards announced FDA approval of Pascal Precision device in this indication.

The trial results were presented in a late-breaking clinical science session at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held September 16-19 in Boston, Massachusetts. The study was published simultaneously by D. Scott Lim, MD, et al in JACC: Cardiovascular Interventions.

Dr. Lim, MD, who is Director, Advanced Heart Valve Center at University of Virginia Health System in Charlottesville, Virginia, is the CLASP IID study principal investigator.

"The CLASP IID randomized trial further establishes the Pascal system as a safe and effective therapy, expanding the armamentarium of transcatheter mitral valve treatment options for patients with DMR," commented Dr. Lim in the company's press release. "Several distinct design characteristics of the Pascal system, including the flexible nitinol design and elongation capability, contribute to the positive outcomes of this study."

According to Edwards, results were reported on 180 patients with 2:1 randomization (117 Pascal; 63 MitraClip), with echo core lab adjudication. The trial included 43 sites in the United States, Canada, and Europe, with most clinical operators new to using the Pascal system and all having experience with the MitraClip system.

Edwards reported that the trial met its primary safety and effectiveness endpoints with the Pascal system demonstrating noninferiority for safety and effectiveness compared to the MitraClip device.

The Pascal system showed low composite major adverse event rate of 3.4% at 30 days, and significant and sustained MR reduction with 97.7% of patients achieving MR ≤ 2+ at 6 months. Additionally, the device demonstrated significant and sustained MR ≤ 1+ with 83.7% of patients at MR ≤ 1+ at 6 months. The study also found favorable ventricular remodeling with improved stroke volume, and patients receiving the Pascal system experienced significant improvements in functional capacity and quality of life, stated Edwards.

Edwards advised that patients treated with the Pascal Precision system in the United States will be enrolled in the TVT Registry for 5 years to build a body of real-world evidence. On August 17, 2022, the company announced that the Pascal Precision system received European CE Mark certification for the treatment of both mitral and tricuspid regurgitation.