Edwards Lifesciences Corp. ((EW)) announced an update on their ongoing clinical study.
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Edwards Lifesciences Corp. is conducting a study titled ‘Transcatheter Tricuspid Valve Replacement (TTVR) in Patients With Severe TR ONgoing Evidence Generation (STRONG) Under Coverage With Evidence Development (CED)’. The study aims to evaluate the long-term health outcomes of patients with severe Tricuspid Regurgitation who have undergone the TTVR procedure using the EVOQUE system. This research is significant as it could provide crucial data on the effectiveness of this treatment.
The intervention being tested is the EVOQUE system, a transcatheter device designed for valve replacement in patients with severe tricuspid regurgitation. It is intended to improve patient outcomes by offering a less invasive alternative to traditional surgery.
The study is observational and retrospective, focusing on a cohort of Medicare patients. It does not involve randomization or masking, and its primary purpose is to gather evidence on the EVOQUE system’s performance in real-world settings.
The study began on February 13, 2025, with the latest update submitted on March 27, 2025. These dates are important as they indicate the study’s current recruiting status and recent developments.
This study could impact Edwards Lifesciences’ stock performance by potentially increasing investor confidence if the results are favorable. The success of the EVOQUE system may also influence the competitive landscape, as other companies in the cardiovascular device industry may need to innovate to keep pace.
The study is ongoing, and further details are available on the ClinicalTrials portal.