The non-surgical heart valve for treating severe pulmonary valve regurgitation first received FDA clearance in March 2021. It treats congenital heart disease patients with native or surgically repaired right ventricular outflow tract (RVOT). Harmony provides a minimally invasive alternative for patients with RVOT anomalies.
However, in April 2022, FDA designated a Class I recall for the system. Medtronic recalled the system because of issues with the delivery catheter. It determined that the bond holding the capsule at the end of the delivery catheter could break during the TPV placement procedure.
The voluntary recall came after Medtronic received reports of six cases of this issue, according to a news release. Medtronic said it worked collaboratively with the FDA to remediate the issue and earn approval to return Harmony to market.
“The relaunch of Harmony TPV underscores our continued commitment to advancing solutions for all people who experience heart disease, and we are proud to be driving innovation forward by offering the first non-surgical solution designed for congenital heart disease patients with severe pulmonary valve regurgitation,” said Nina Goodheart, SVP and president of Medtronic’s Structural Heart & Aortic business.
Medtronic now offers Harmony in the U.S. It also holds regulatory approval in Japan.
“For congenital heart disease patients with severe pulmonary valve regurgitation, utilizing a valve that works with their anatomy is key to preventing risks such as right-sided heart failure, and optimizing outcomes while minimizing the disruption to their lives,” said Dr. Matthew J. Gillespie, director of interventional cardiology and co-director of the Valve Center at Children’s Hospital of Philadelphia. “I am pleased to be able to once again offer Harmony TPV as an option to patients who require pulmonary valve replacement.