Edwards Lifesciences Corp. ((EW)) announced an update on their ongoing clinical study.
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Study Overview: Edwards Lifesciences Corp. is conducting the PROGRESS Trial, officially titled ‘The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement.’ The study aims to evaluate the safety and effectiveness of the Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in patients with moderate, calcific aortic stenosis. This research is significant as it could influence treatment protocols for this condition.
Intervention/Treatment: The trial tests the SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA heart valves, which are designed to replace the aortic valve in patients with moderate aortic stenosis. The intervention involves implanting these devices via Transcatheter Aortic Valve Replacement (TAVR).
Study Design: This interventional study uses a randomized, parallel assignment model with no masking. The primary purpose is treatment, comparing the outcomes of TAVR against clinical surveillance in managing moderate aortic stenosis.
Study Timeline: The study began on May 12, 2021, and is currently recruiting participants. The latest update was submitted on October 9, 2025. These dates are crucial for tracking the study’s progress and anticipated completion.
Market Implications: The outcome of this study could significantly impact Edwards Lifesciences’ stock performance and investor sentiment. Positive results may enhance the company’s market position in the competitive heart valve industry, potentially influencing competitors’ strategies.
The study is ongoing, with further details available on the ClinicalTrials portal.