Edwards Lifesciences got the green light from the FDA for its first adjustable heart valve for kids.

Oct 2, 2026, 10:56 AM ETProductRead the original at Benzinga

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Edwards can now offer a valve that grows with children and may spare them repeat open-heart surgery. Trial results were strong, though 3 frames fractured and 2 valves showed reduced leaflet motion without symptoms; longer follow-up is planned.

EW · Edwards Lifesciences Corp.

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This gives Edwards another option for children with congenital heart disease and may help doctors avoid repeat open-heart surgery. The trial results support the device, though some frames broke and some leaflets moved less. No affected children had symptoms, and a 10-year study will track longer-term results.

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