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

  Ref: PRNewswire | Image: Inter Brand Health