Edwards Lifesciences (NYSE:EW) announced data confirming its transcatheter edge-to-edge repair (TEER) as safe and effective.
CLASP IID compared Edwards’ Pascal system and Abbott’s MitraClip system. The study determined that the two contemporary TEER therapies are safe and effective in patients with degenerative mitral regurgitation (DMR).
Results from the trial were presented at the 34th Transcatheter Cardiovascular Therapeutics (TCT) and published simultaneously in JACC: Cardiovascular Interventions.
Trial results
Patients enrolled in the CLASP IID pivotal trial had severe symptomatic DMR and were determined to be at a prohibitive surgical risk. The trial met its primary safety and effectiveness endpoints, according to a news release. Pascal demonstrated non-inferiority for safety and effectiveness compared to MitraClip.
In the trial, Pascal demonstrated a low composite major adverse event rate of 3.4 percent at 30 days, Edwards said. It also produced significant and sustained MR reduction as 97.7% of patients achieved MR ≤2+ at six months.
Additionally, Pascal demonstrated significant and sustained MR ≤1+ with 83.7 percent of patients at MR ≤1+ at six months. It showed favorable ventricular remodeling with improved stroke volume. Patients receiving Pascal experienced significant improvements in functional capacity and quality of life.
“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,” said Dr. Scott Lim, director, Advanced Heart Valve Center at University of Virginia Health System and CLASP IID study principal investigator. “Several distinct design characteristics of the Pascal system, including the flexible nitinol design and elongation capability, contribute to the positive outcomes of this study.”
CLASP IID featured 180 patients randomized at 2:1 to Pascal (117) and MitraClip (63). It included 43 sites across the U.S., Canada and Europe.
“As we consider the many DMR patients who are suffering with debilitating symptoms and could benefit from a TEER procedure, we are very pleased with the outcomes from the CLASP IID trial,” said Bernard J. Zovighian, Edwards corporate VP, transcatheter mitral and tricuspid therapies. “Edwards continues to prioritize evidence generation with world-class data in support of our patient-driven therapies, and we are proud to support this and multiple other pivotal trials as we work to transform treatment for these patients in need.”
Edwards and Abbott go head-to-head
Last week, the FDA approved the Edwards Pascal system for TEER in patients with DMR. The Pascal system features independent grasping, atraumatic clasp and closure and the ability to elongate. According to a news release, it enables safe and effective treatment for patients with DMR. It includes an intuitive catheter and handle for maneuverability and stability to offer precise navigation and implant delivery.
Abbott at TCT also presented positive study results as its MitraClip G4 proved effective in treating MR.
BTIG analyst Marie Thibault wrote that physicians at TCT cautioned against the direct comparison between the Edwards and Abbott devices. However, they praised the high portion of sustained mild or less MR in the PASCAL arm of the study.
“As one physician panelist put it, ‘It’s been a good day for TEER therapy,’” Thibault wrote. “We view CLASP IID as a clear success in showing PASCAL is safe, effective and commercially viable.”