Pulmonary Valve Replacement with the Harmony Transcatheter Valve

Also known as: Harmony Valve, Harmony Trans catheter Pulmonary Valve

What is Harmony Transcatheter Pulmonary Valve?

Approximately one in five patients born with CHD have an abnormality of their right ventricular outflow tract (RVOT) that makes it difficult for blood to travel from the heart to the lungs. At least 20 percent of these patients require open-heart surgery or other interventions early in life.  Early surgery on the pulmonary valve often results in dysfunction of the valve in the long-term in the form of pulmonary regurgitation.

The Medtronic Harmony Transcatheter Pulmonary Valve is the first FDA-approved valve that offers older children and adults in need of pulmonary valve replacement because of a dysfunctional native pulmonary valve an alternative treatment option that is less invasive than open-heart surgery. The Harmony TPV is designed to delay, or potentially completely avoid, patients’ need for open-heart surgery by restoring pulmonary valve function with a minimally invasive procedure. The device was approved by the Food and Drug Administration (FDA) in March 2021.

What happens during the procedure?

The Harmony valve is loaded onto a catheter and delivered via a small incision in the femoral vein or in the neck in order to place it directly inside the heart. This is performed in the cardiac catheterization laboratory.

Is any special preparation needed? 

As with any cardiac catheterization, the patient will be asked to avoid consuming food, drink and certain medicines at least 6 to 8 hours prior to the procedure. Please follow your procedure instructions provided by the care team.

What are the risk factors? 

The risk of a severe complication is very small. Mild or transient symptoms may occur, including bruising around where the catheter is inserted, or nausea related to general anesthesia.

Reviewed by: Lourdes Prieto, MD

This page was last updated on: September 16, 2025 12:52 PM