Edwards Lifesciences Corp. ((EW)) announced an update on their ongoing clinical study.
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The Edwards Lifesciences Corp. is conducting a pivotal clinical trial titled ‘A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation.’ The study aims to assess the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with severe tricuspid regurgitation who are at an intermediate or higher risk of mortality from surgery.
The intervention being tested is the Edwards PASCAL System, a device designed for transcatheter tricuspid valve repair, used in conjunction with optimal medical therapy (OMT). The study compares this combination to OMT alone.
This interventional study is randomized with a parallel assignment model and no masking. Its primary purpose is treatment, focusing on evaluating the effectiveness of the device in improving patient outcomes.
The study began on December 11, 2019, and is currently recruiting participants. The last update was submitted on July 31, 2025. These dates are crucial as they indicate the study’s progress and timeline for potential results.
The update on this study could influence Edwards Lifesciences’ stock performance positively, as successful results may enhance investor confidence and market position. It also highlights the competitive landscape in the medical device industry, where innovation is key to maintaining a competitive edge.
The study is ongoing, with further details available on the ClinicalTrials portal.