Edwards Lifesciences Corp. ((EW)) announced an update on their ongoing clinical study.
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Study Overview: The MiCLASP Post Market Clinical Follow-Up (PMCF) Study, officially titled ‘Transcatheter Repair of Mitral Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post Market Clinical Follow-Up (PMCF),’ aims to evaluate the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in treating mitral regurgitation and insufficiency. This study is significant as it provides critical post-market data on a key medical device used in heart valve repair.
Intervention/Treatment: The study tests the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System. These devices are designed for transcatheter mitral valve repair, offering a less invasive treatment option for patients with mitral valve issues.
Study Design: This is an observational study with a cohort model and a prospective time perspective. The primary purpose is to gather real-world data on the device’s performance post-market, without any allocation or masking involved.
Study Timeline: The study began on December 19, 2019, and is currently recruiting participants. The last update was submitted on June 25, 2025. These dates are crucial as they indicate the study’s progress and the latest data collection efforts.
Market Implications: The ongoing study could influence Edwards Lifesciences Corp.’s stock performance by providing valuable data on the PASCAL system’s effectiveness. Positive results may boost investor confidence and position Edwards favorably against competitors in the transcatheter valve repair market.
The study is ongoing, with further details available on the ClinicalTrials portal.