FDA Approves Edwards’ Sapien 3 With The Alterra Prestent For Pulmonary Regurgitation

The new device combines Edwards’ market-leading Sapien 3 transcatheter heart valve with its Alterra adaptive prestent device to treat patients with severe pulmonary regurgitation due to congenital valve defects.

Edwards Lifesciences is preparing to roll out the Sapien 3 transcatheter pulmonic valve (TPV) system, a version of its successful Sapien 3 transcatheter aortic valve replacement (TAVR) system that also includes a prestent device to make it suitable to treat pulmonary regurgitation.

On 16 December, the US Food and Drug Administration approved a premarket approval supplement indicating Sapien 3 TPV for both pediatric and adult patients with severe pulmonary regurgitation as...

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