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The FDA Approves Sapien 3 with Alterra in Pulmonary Position

The FDA Approves Sapien 3 with Alterra in Pulmonary Position

The US Food and Drug Administration (FDA) has cleared the SAPIEN 3 valve with the Alterra adaptive pre-stent for implantation in pulmonary position.  According to Edwards Lifesciences, this new system developed for pulmonary valve is capable of compensating a wide variety of sizes and morphologies of the right ventricular outflow tract, allowing for stable valve implantation.

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