Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent System - Pulmonic Kit - Valve-non-specific transcatheter heart valve bioprosthesis

Intended purpose

The 29mm Edwards SAPIEN 3 transcatheter heart valve system with Alterra Adaptive Prestent is indicated for use in the management of patients with pulmonary regurgitation who have a native or surgically repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement.

Functional description

The bioprosthesis with present is intended for use in patients requiring pulmonary heart valve replacement. The delivery system and accessories are intended to facilitate placement of the bioprosthesis and prestent via the transfemoral access approach.