Edwards Lifesciences Corp. ((EW)) announced an update on their ongoing clinical study.
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Edwards Lifesciences Corp. is conducting a study titled ‘Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device’ (TRISCEND III EU). The study aims to assess the safety and clinical efficacy of the Edwards EVOQUE system, a transcatheter tricuspid valve replacement device, in real-world settings across Europe. This investigation is significant as it addresses tricuspid valve regurgitation and other cardiovascular diseases, potentially offering a less invasive treatment option.
The intervention being tested is the Transcatheter Tricuspid Valve Replacement using the Edwards EVOQUE system. This device is designed to replace the tricuspid valve via a transcatheter approach, providing a novel treatment for patients with tricuspid valve regurgitation.
The study is observational, following a cohort model with a prospective time perspective. It is a single-arm, multi-center study, meaning all participants receive the same treatment, and the primary purpose is to observe the real-world application and outcomes of the device.
The study began on August 12, 2024, with the latest update submitted on October 29, 2024. These dates are crucial as they mark the timeline of the study’s progress and the ongoing recruitment status, indicating active data collection and analysis phases.
For investors, the successful outcome of this study could positively influence Edwards Lifesciences’ stock performance by reinforcing its position in the cardiovascular device market. The EVOQUE system’s success could also impact competitors by setting new standards for tricuspid valve replacement therapies.
The study is currently recruiting, and further details are available on the ClinicalTrials portal.
