Edwards Lifesciences Corp. ((EW)) announced an update on their ongoing clinical study.
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Edwards Lifesciences Corp. is conducting a pivotal clinical trial titled Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF). The study aims to evaluate the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System compared to the Abbott MitraClip in patients with mitral regurgitation, a condition where the heart’s mitral valve doesn’t close tightly, allowing blood to flow backward in the heart.
The intervention being tested is the Edwards PASCAL System, a device designed for transcatheter mitral valve repair. It is intended to offer a less invasive treatment option for patients with degenerative and functional mitral regurgitation who are at prohibitive risk for traditional surgery.
This interventional study is randomized with a parallel intervention model and has no masking, focusing primarily on treatment. It involves comparing the Edwards PASCAL System against the Abbott MitraClip System, which serves as the active comparator.
The study began on October 10, 2018, with the latest update submitted on May 19, 2025. These dates are crucial as they indicate the study’s progress and ongoing recruitment status, which can influence investor decisions.
The outcome of this trial could significantly impact Edwards Lifesciences’ stock performance and investor sentiment, especially given the competitive landscape with Abbott. Successful results could enhance Edwards’ market position in the transcatheter mitral valve repair sector.
The study is currently ongoing, with further details available on the ClinicalTrials portal.