EW - Edwards Lifesciences wins approval for Sapien 3 with Altera prestent

The FDA has approved the use of Edwards Lifesciences' (EW -3.0%)  SAPIEN 3 transcatheter valve with the Alterra adaptive prestent for patients with severe pulmonary regurgitation. The use of Alterra makes up for variations in size and morphology of the right ventricular outflow tract allowing for a stable landing zone for the SAPIEN 3 valve. Sapien 3 with Alterra is indicated for pediatric and adult patients with severe pulmonary regurgitation who have a native or surgically repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement. Check out JP Morgan's recent upgrade of Edwards shares.

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Edwards Lifesciences wins approval for Sapien 3 with Altera prestent