This is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name:  Harmony Transcatheter Pulmonary Valve System
PMA Applicant:  Medtronic, Inc.
Address:  3576 Unocal Place, Santa Rosa, CA 95403
Approval Date:   March 26, 2021
Approval Letter:   Approval Order

What is it? 

The Harmony Transcatheter Pulmonary Valve (TPV) System is used to treat a leaky native or surgically repaired right ventricular outflow tract (RVOT; the part of the heart that carries blood to the lungs). The Harmony TPV System consists of a transcatheter pulmonary valve and a delivery catheter. The transcatheter pulmonary valve is made of pig heart tissue and is attached to a flexible, self-expanding nickel-titanium (Nitinol) wire frame for support.

How does it work? 

The doctor inserts the catheter through a blood vessel (vein) in the groin or in the neck to reach the right side of the heart. The catheter is then placed into position within the RVOT. The TPV is then released from the catheter allowing it to expand on its own and anchor to the RVOT. Once the TPV is in place, it opens and closes like a door to force the blood to flow in the correct direction out of the heart to the lungs.

When is it used? 

The Harmony TPV is used to treat pediatric and adult patients who have severe pulmonary regurgitation (blood leaking backward into the right lower chamber of the heart) associated with their native or surgically repaired RVOT, a condition that often results from congenital heart disease.

What will it accomplish? 

The Harmony TPV is intended to improve blood flow to the lungs in patients with severe pulmonary regurgitation without open-heart surgery, which is the current standard of care. The use of the Harmony TPV may delay the time before a patient needs additional open-heart surgery. It can also potentially reduce the total number of open-heart surgeries required over an individual’s lifetime. In a clinical study, about 89 out of every 100 patients treated with the Harmony TPV System had acceptable pulmonary valve function at six months without needing another medical procedure on their pulmonary valve.

When should it not be used? 

The Harmony TPV should not be used in patients who:

• Have an infection in the heart or other area in the body.
• Cannot tolerate blood thinning medicines.
• Have sensitivity to Nitinol (Titanium or Nickel).

Additional information (including warnings, precautions, and adverse events): 

• Summary of Safety and Effectiveness
• Patient Labeling: Harmony Transcatheter Pulmonary Valve (TPV) Information for You and Your Family
• Physician Labeling: Harmony TPV 22 and TPV 25 Transcatheter Pulmonary Valves and Delivery Catheter system Instructions for Use
• PMA Database Entry
• Press Release: FDA Approves First in the World Device to Treat Patients with Congenital Heart Disease