- FDA on Friday said it approved Medtronic’s catheter-based treatment for pediatric and adult patients with severe pulmonary valve regurgitation in the right ventricular outflow tract, which carries blood from the heart to the lungs.
- The Harmony transcatheter pulmonary valve offers a less-invasive treatment alternative to open-heart surgery for patients with the condition, which typically is the result of a congenital heart defect. FDA said the Medtronic device is the first non-surgical valve approved to treat these patients.
- The Harmony valve was granted FDA premarket approval after receiving the agency’s breakthrough device designation to expedite its development. Approval was based on a 70-patient clinical study in which all patients achieved the primary safety endpoint of no death within 30 days of implant and 89.2% of patients with echocardiography data met the primary effectiveness endpoint of no additional procedures related to the device plus acceptable blood flow at six months.