Edwards Lifesciences Corp. ((EW)) announced an update on their ongoing clinical study.
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Edwards Lifesciences Corp. is collaborating with World Health Research Inc. on a study titled ‘A Prospective Cohort Study of Bicuspid Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm for Sapien 3 Balloon Expandable Valve.’ The study aims to evaluate the impact of the ABC Bicuspid Sizing Algorithm on clinical outcomes for patients with bicuspid aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). Key objectives include assessing technical success post-procedure and device success 30 days after the procedure.
The intervention being tested is the ABC Bicuspid Sizing Algorithm, which assists in determining the appropriate procedure type and valve size for TAVR patients. This algorithm guides the evaluation of diagnostic images and may suggest further assessments using gated CT or AI-based simulations.
This observational study follows a prospective cohort model, focusing on patients already evaluated for TAVR. It does not involve random allocation or masking, as it primarily aims to observe outcomes based on the algorithm’s application.
The study began on April 16, 2025, with a recent update on May 26, 2025. These dates mark the study’s initiation and the latest information available, indicating ongoing recruitment and data collection.
For investors, the study’s outcomes could influence Edwards Lifesciences’ market position, particularly if the algorithm demonstrates significant improvements in procedural success. Positive results may enhance investor confidence and affect stock performance, especially in a competitive landscape where innovation is key.
The study is currently recruiting, with further details accessible on the ClinicalTrials portal.