FDA says Medtronic heart valve satisfies study goals

Medtronic's Melody transcatheter pulmonary valve, designed for replacing the pulmonary valve without the need for open-heart surgery, met efficacy and safety goals in a study of patients with a congenital heart defect, according to the FDA. The agency, however, found an 18% fracture rate in stents that are part of the heart valve. An FDA panel is set to meet Wednesday to review the device.

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