Medtronic’s Harmony Transcatheter Pulmonary Valve Replacement System Is Relaunched

February 22, 2023—Medtronic announced the relaunch of its Harmony transcatheter pulmonary valve (TPV) system, a minimally invasive alternative to open heart surgery for congenital heart disease patients with native or surgically repaired right ventricular outflow tract (RVOT).

According to the company, Harmony TPV was designed to treat patients with RVOT anomalies who develop severe pulmonary valve regurgitation. The Harmony TPV provides these patients with a minimally invasive alternative to the current standard of care—open heart surgery or other interventions early in life—to address these malformations.

“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,” commented Matthew J. Gillespie, MD, in Medtronic’s press release. “I am pleased to be able to once again offer Harmony TPV as an option to patients who require pulmonary valve replacement.” Dr. Gillespie is Director of Interventional Cardiology and Codirector of the Valve Center at Children’s Hospital of Philadelphia in Philadelphia, Pennsylvania.

The company advised that the Harmony TPV system received FDA approval in 2021 based on the Harmony TPV Clinical Study that demonstrated safety and effectiveness up to 6 months with no significant reinterventions.

In March 2022, Medtronic initiated a voluntary recall of the Harmony delivery catheter system because there were six reported cases of the bond holding the capsule at the end of the delivery catheter breaking.

Medtronic stated that the company worked collaboratively with the FDA to remediate the issue and earn FDA approval to return the device to market. The Harmony TPV device is now commercially available for use in the United States and has received regulatory approval in Japan.