Edwards Lifesciences Corp. ((EW)) announced an update on their ongoing clinical study.
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Edwards Lifesciences Corp. is conducting 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).’ The study aims to evaluate the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and its Precision counterpart in improving mitral regurgitation (MR), functional status, and quality of life in patients, providing crucial insights into post-market performance.
The study tests the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System, both devices designed for transcatheter mitral valve repair, aiming to enhance patient outcomes in MR treatment.
This observational study follows a cohort model with a prospective time perspective, focusing on collecting real-world data on the devices’ performance without specific allocation or masking processes, emphasizing its practical application in clinical settings.
The study began on August 23, 2019, with its primary completion and estimated completion dates yet to be determined. The latest update was submitted on June 25, 2025, indicating ongoing recruitment and data collection efforts.
The study’s progress could influence Edwards Lifesciences’ stock performance by reinforcing investor confidence in the company’s innovative capabilities and market position. As the medical device industry remains competitive, successful outcomes could enhance Edwards’ standing against rivals.
The MiCLASP study is ongoing, with further details available on the ClinicalTrials portal.