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Medtronic’s Transcatheter Harmony Valve For Congenital Pulmonary Defect Wins FDA Approval

 
• By Elizabeth Orr

The Harmony transcatheter pulmonary valve can be used to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation as a result of a congenital malformation of the right ventricular outflow tract.

A pair of adult-sized hands surround the hands of a child, which themselves hold a red toy heart with an EEG line design on it.
• Source: Shutterstock

A newly approved minimally invasive treatment for congenital heart defects could help up to 8,000 newborns per year, the US Food and Drug Administration announced on 26 March.

The agency approved a PMA for Medtronic’s Harmony transcatheter pulmonary valve (TPV) system in pediatric and adult patients . Harmony...

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FDA Changes Fail To Diminish US Appeal To European Medtech Industry

 
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