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 ‘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 Repair System in patients with severe tricuspid regurgitation who are at an intermediate or greater risk of mortality from surgery.
The intervention being tested is the Edwards PASCAL Transcatheter Valve Repair System, a device designed for transcatheter tricuspid valve repair, used alongside optimal medical therapy (OMT) to treat tricuspid regurgitation.
This interventional study uses a randomized, parallel assignment model with no masking. The primary purpose is treatment, comparing the Edwards PASCAL system with OMT against OMT alone.
The study began on September 18, 2019, with an estimated primary completion date and last update on September 18, 2025. These dates are crucial as they mark the progress and expected conclusion of the study, providing timelines for potential market entry.
The outcome of this study could significantly impact Edwards Lifesciences’ stock performance by potentially enhancing its product portfolio and competitive edge in the cardiovascular device market. Positive results may boost investor confidence, while also influencing competitors in the tricuspid valve repair segment.
The study is currently recruiting, with further details available on the ClinicalTrials portal.