Edwards Lifesciences Corp. ((EW)) announced an update on their ongoing clinical study.
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Edwards Lifesciences Corp. is currently conducting the ALT-FLOW II Trial, officially titled ‘A Randomized, Sham-controlled Clinical Trial for Evaluation of the Edwards APTURE Transcatheter Shunt System.’ The study aims to evaluate the safety, performance, and effectiveness of the Edwards APTURE transcatheter shunt system in treating patients with heart failure with preserved or mildly reduced ejection fraction who remain symptomatic despite standard medical therapy. This trial is significant as it addresses a critical need for effective treatments in this patient population.
The intervention being tested is the Edwards APTURE transcatheter shunt system, a device designed to improve heart function in patients with specific types of heart failure. The study compares this device against a sham procedure to determine its true efficacy.
The study is designed as a prospective, multi-center, randomized, sham-controlled, double-blinded trial. Participants are randomly assigned to receive either the APTURE shunt or a sham procedure, with both participants and outcomes assessors blinded to the assignment. The primary purpose of the study is treatment-focused.
The study began on April 1, 2023, with recruitment currently ongoing. The last update was submitted on June 27, 2025. These dates are crucial as they indicate the study’s progress and the timeline for potential results that could impact clinical practice and market dynamics.
The outcome of this study could significantly influence Edwards Lifesciences’ stock performance and investor sentiment, especially if the results demonstrate a clear benefit of the APTURE system. This could also impact competitors in the heart failure treatment market, potentially reshaping industry standards.
The ALT-FLOW II Trial is ongoing, with further details available on the ClinicalTrials portal.