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Edwards Lifesciences Receives FDA Approval for AUTUS Valve, the First Surgical Pulmonary Valve for Pediatric Patients

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FDA approves Autus size-adjustable heart valve for children with congenital defects

The FDA has approved Edwards Lifesciences' Autus Size-Adjustable Valve, the first surgical pulmonary valve designed to expand as pediatric patients grow. The device could significantly reduce the need for multiple open-heart surgeries in children born with certain heart defects.

Oct 1, 2026·4 sources
FDA approves Autus size-adjustable heart valve for children with congenital defects
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Other sources for this story

Engadget

FDA approves artificial heart valve for kids that grows as they do - Engadget

Medicalxpress

A heart valve that grows up with the patient wins FDA approval

Medpagetoday

FDA Approves Only Surgical Pulmonary Valve Fit for Growing Kids