Medtronic’s Harmony Transcatheter Pulmonary Valve Receives the US FDA’s Approval for Patients with Congenital Heart Disease

March 30, 2021 Auto Bot MedTech, regulatory 0

Shots:

  • The approval is based on clinical data from the Harmony TPV clinical study that showed freedom from mortality & acceptable hemodynamic function @30days & 6mos. respectively
  • The study demonstrated that patients treated with Harmony TPV experienced no significant reinterventions, reoperations or endocarditis @6mos.
  • Harmony TPV is the first minimally invasive alternative for patients with severe pulmonary regurgitation who have a native or surgically-repaired right ventricular outflow tract

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Inter Brand Health

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