FDA approves Medtronic’s Harmony transcatheter pulmonary valve system

FDA has approved a Medtronic device described as a first-in-the-world, non-surgical heart valve to treat severe pulmonary valve regurgitation — a condition often arising from congenital heart disease.

The Harmony transcatheter pulmonary valve system could delay the time before someone with congenital heart disease might need additional open-heart surgery, FDA said today. The Harmony device could also potentially reduce the number of open-heart surgeries needed over a person’s lifetime.

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