Edwards Lifesciences Corp. ((EW)) announced an update on their ongoing clinical study.
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Edwards Lifesciences Corp. is conducting a clinical study titled ‘Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post-Market Clinical Follow up.’ The study aims to evaluate the safety and effectiveness of the Edwards PASCAL and PASCAL Precision Transcatheter Valve Repair Systems in treating tricuspid regurgitation, focusing on improving patients’ functional status and quality of life.
The intervention involves the use of two devices: the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System. Both are designed for the percutaneous reconstruction of insufficient tricuspid valves.
This observational study follows a cohort model with a prospective time perspective. It does not involve patient allocation or masking, emphasizing real-world data collection to assess the devices’ performance post-market.
The study commenced on January 15, 2021, with its primary completion and estimated overall completion slated for June 30, 2025. These dates are crucial for tracking the study’s progress and anticipating when results might impact the market.
For investors, this study could influence Edwards Lifesciences’ stock performance, as positive outcomes may enhance the company’s market position in the transcatheter valve repair space. Competitors in the medical device industry will be keenly observing these developments.
The study is currently active but not recruiting, with further updates available on the ClinicalTrials portal.