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Edwards Lifesciences' Autus valve has received FDA approval, with the possibility of later expansion using a balloon catheter as the child grows, potentially reducing the need for repeated open-heart surgeries. The decision was based on a study involving 62 children, with follow-up planned for 10 years.
The Centers for Medicare and Medicaid Services approved coverage for transcatheter aortic valve replacement for patients with severe aortic stenosis even without symptoms. Analysts expect Edwards Lifesciences to benefit particularly, while evidence continues to be collected on this patient group.