Edwards Lifesciences Corp. ((EW)) announced an update on their ongoing clinical study.
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Edwards Lifesciences Corp. has initiated the MITRIS China Post Market Clinical Follow-up (PMCF) Study, officially titled ‘Post-Market Clinical Follow-up Study of Edwards Lifesciences MITRIS RESILIA Mitral Valve in Chinese Population.’ The study aims to gather data on the safety and performance of the MITRIS RESILIA Mitral Valve in patients needing mitral valve replacement, highlighting its significance in improving patient outcomes in China.
The intervention being tested is the MITRIS RESILIA Mitral Valve, a device designed for the surgical replacement of native or prosthetic mitral valves. Its purpose is to enhance the safety and effectiveness of mitral valve surgeries.
This observational study is structured as a multicenter, prospective, single-arm cohort study. It will involve up to 250 subjects who have received the MITRIS RESILIA Mitral Valve, focusing on collecting clinical outcomes over time.
The study is set to start in July 2025, with the primary completion and estimated completion dates yet to be determined. The last update was submitted on July 8, 2025, indicating the study’s ongoing preparation phase.
The initiation of this study could positively influence Edwards Lifesciences’ stock performance by reinforcing investor confidence in its innovative medical solutions. As the company expands its presence in the Chinese market, it may face competition from other global and local medical device manufacturers, but its focus on clinical validation could offer a competitive edge.
The MITRIS China PMCF Study is currently not yet recruiting, with further details available on the ClinicalTrials portal.