About 1.3 children around the world each year are born with congenital heart disease, according to the Minneapolis-based nonprofit Children’s HeartLink. The Harmony system provides a minimally invasive alternative to open-heart surgery for congenital heart disease patients with native or surgically repaired right ventricular outflow tract (RVOT).

The Harmony system first received FDA clearance in March 2021. However, the FDA designated a Class I recall for the system in April 2022 after Medtronic reported that the bond holding the capsule at the end of the delivery catheter could break during TPV placement.

Medtronic relaunched Harmony in the U.S. in February 2023 and soon had positive two-year results to report for the system.