About 5 years after the Melody Transcatheter Pulmonary Valve was approved by the FDA under a Humanitarian Device Exemption (HDE), the Medtronic implant has now been given full PMA approval by the agency, claims the company. The Melody TPV is a minimally invasive approach to prolonging the time between open-heart surgeries for patients with a dysfunctional right ventricular outflow tract conduit caused by congenital heart disease. An HDE is intended ...
via Medindia Health News
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