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3 results found


Congenital heart

COMPASSION S3 Post Approval

The SAPIEN 3 THV System was recently approved for use in patients with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention. The objective of ...


Congenital heart

Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent

The purpose of this study is to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with the Alterra Adaptive Prestent, which is approved by the U.S. Food and Drug ...


Congenital heart

Medtronic Harmony TPV Post-Approval Study

The purpose of this study is to evaluate the functionality of transcatheter implantation (a minimally invasive procedure) of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV). Significant pulmonary regurgitation (abnormal reversal of blood flow in the ...