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FDA Approves Only Surgical Pulmonary Valve Fit for Growing Kids
The size-adjustable valve can be expanded as children grow, and a 62-patient study found acceptable performance with no more than mild regurgitation.
- On Thursday, the Food and Drug Administration approved the Autus Size-Adjustable Valve for surgical pulmonary valve replacement in children with congenital heart disease, addressing a critical unmet need in pediatric cardiac care.
- Traditional animal-tissue valves cannot accommodate growth, forcing children with congenital pulmonary valve disease to undergo multiple surgeries; the Autus valve addresses this by utilizing polymeric material and balloon catheter expansion to grow with the patient.
- In a pivotal study of 62 pediatric patients across 12 U.S. sites, the device met all primary safety endpoints, with 100% of participants free from device-related complications through 30 days and no valve reinterventions through six months.
- Michelle Tarver, director of the FDA's Center for Devices and Radiological Health, stated the valve gives doctors "far fewer trips to the operating room," while surgeon Emile Bacha of NewYork-Presbyterian/Columbia University Irving Medical Center noted it provides "a new way to think about long-term care planning."
- This approval marks the first time the FDA has authorized a valve using polymeric leaflet material; the agency granted the device breakthrough designation, and patients in the pivotal study will continue to be monitored for 10 years.
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The U.S. Food and Drug Administration has approved the first heart valve that can expand after surgery to grow with children.
·Tehran, Iran (Islamic Republic of)
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FDA Clears First Expandable Heart Valve for Growing Children
The FDA approved Edwards Lifesciences' Autus Size-Adjustable Valve, the first pulmonary valve designed to expand with a child's growth from 13mm to 22mm. Early trial data from 62 patients showed strong safety and performance with no reinterventions at six months. This could sharply reduce repeat open-heart surgeries for children with congenital heart disease.
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Total News Sources18
Leaning Left1Leaning Right2Center6Last UpdatedBias Distribution67% Center
Bias Distribution
- 67% of the sources are Center
67% Center
11%
C 67%
R 22%
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