Edwards Lifesciences Corp. ((EW)) announced an update on their ongoing clinical study.
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Edwards Lifesciences Corp. is currently conducting a pivotal clinical trial titled ‘Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial.’ The study aims to evaluate the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with symptomatic severe tricuspid regurgitation who are at an intermediate or greater risk of mortality with traditional tricuspid valve surgery. This trial is significant as it could offer a less invasive treatment option for patients with this condition.
The intervention being tested is the Edwards PASCAL Transcatheter Valve Repair System, a device designed for transcatheter tricuspid valve repair. The system is intended to be used alongside optimal medical therapy (OMT) to improve patient outcomes.
The study is interventional, with a randomized, parallel assignment model. There is no masking involved, and the primary purpose is treatment. This design allows for a clear comparison between the device plus OMT and OMT alone.
The trial began on December 11, 2019, and is currently recruiting participants. The last update was submitted on June 30, 2025. These dates are crucial as they indicate the study’s progress and timeline for potential results.
Market implications of this study could be significant for Edwards Lifesciences, as positive results may enhance their market position and influence stock performance. The trial’s outcome could also impact competitors within the medical device industry, particularly those focusing on heart valve treatments.
The study is ongoing, and further details are available on the ClinicalTrials portal.