Edwards Lifesciences Completes Key Study on SAPIEN XT THV

Edwards Lifesciences Corp. (EW) announced an update on their ongoing clinical study.

Edwards Lifesciences Corp. recently completed the COMPASSION XT PAS, a post-approval study officially titled ‘New Enrollment SAPIEN XT Post-Approval Study.’ The study aimed to confirm the safety and effectiveness of the SAPIEN XT Transcatheter Heart Valve (THV) System in patients with pulmonary valve dysfunction, specifically those with a dysfunctional right ventricular outflow tract (RVOT) conduit requiring intervention. This study holds significant importance as it evaluates the device’s performance in a real-world, post-market setting.

The intervention tested in this study is the SAPIEN XT THV, a transcatheter heart valve designed for implantation in the pulmonic position. Its primary purpose is to treat patients with pulmonary valve insufficiency and stenosis, offering a less invasive alternative to traditional surgical methods.

The study was observational in nature, following a cohort model with a prospective time perspective. This design allowed researchers to observe outcomes in a real-world setting without manipulating variables, focusing on the natural progression and treatment effects in the patient cohort.

The study began on October 19, 2016, and was completed with the last update submitted on December 12, 2025. These dates are crucial as they mark the timeline of the study’s progression and the availability of its findings, which can influence clinical practices and regulatory decisions.

The completion of this study could positively impact Edwards Lifesciences’ stock performance and investor sentiment, as successful results may enhance the market confidence in the SAPIEN XT THV. In the competitive landscape of cardiovascular devices, such updates are pivotal for maintaining a leading position and driving innovation.

The study is now completed, with further details available on the ClinicalTrials portal.