BOSTON, Sept. 17, 2022 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE:EW) announced results from CLASP IID, the first randomized controlled trial that directly compares two contemporary transcatheter edge-to-edge repair (TEER) therapies. The study confirms TEER as a safe and effective therapy in patients with degenerative mitral regurgitation (DMR). Results from the CLASP IID pivotal trial were presented as a late-breaking clinical science session at the 34th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, and published simultaneously in JACC: Cardiovascular Interventions.
Patients enrolled in the CLASP IID pivotal trial had severe symptomatic DMR and were determined to be at prohibitive surgical risk. The CLASP IID trial met its primary safety and effectiveness endpoints, with the PASCAL system demonstrating non-inferiority for safety and effectiveness compared to the MitraClip device. The PASCAL device showed:
- Low composite adverse major event rate of 3.4 percent at 30 days, and
- Significant and sustained MR reduction with 97.7 percent of patients achieving MR ≤2+ at six months.
The PASCAL system further demonstrated significant and sustained MR ≤1+ with 83.7 percent of patients at MR ≤1+ at six months. PASCAL system results 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 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 Scott LimMD, director, Advanced Heart…