Medtronic’s Harmony Transcatheter Pulmonary Valve Evaluated at 1 Year

April 30, 2021—The Society for Cardiovascular Angiography & Interventions (SCAI) announced that study results validate the effectiveness of the Harmony transcatheter pulmonary valve (TPV) system (Medtronic) for patients with congenital heart disease (CHD) and severe pulmonary regurgitation (PR).

The Harmony TPV is designed to be a less invasive treatment option for patients with irregularity in their right ventricular outflow tract (RVOT) needing pulmonary valve placement to restore valve function. In March 2021, the Harmony TPV system was granted FDA approval for use in the United States.

The 1-year outcomes from the pivotal trial and 30-day outcomes from the continued-access study were presented as late-breaking clinical science at the SCAI 2021 Virtual Scientific Sessions. SCAI noted that investigators plan to follow-up through 5 years. A postapproval study will also be conducted with follow-up to 10 years.

According to SCAI, the prospective, nonrandomized study was conducted at ten sites in the United States, Canada, and Japan and included 67 patients who received the valve. Primary safety and effectiveness endpoints included freedom from procedure- or device-related mortality at 30 days and percentage of patients with acceptable hemodynamic function at 6 months and no Harmony valve intervention.

SCAI reported that investigators analyzed two sizes of the Harmony valve: a 22-mm valve (TPV22) and a modified version of the original 25-mm valve (mTPV25). Clinical outcomes through 1 year included no mortality, endocarditis, major stent fractures, or need for surgical intervention. One patient underwent a valve-in-valve intervention for residual stenosis. More than 90% of patients reported having little to no PR during follow-up visits.

The study’s Principal Investigator is Thomas Jones, MD. Dr. Jones is Director, Cardiac Catheterization Laboratories at Seattle Children’s Hospital in Seattle, Washington.

“This is a brand-new class of cardiac devices designated to help a very specific patient population where no less invasive, percutaneous treatment options were available until now,” commented Dr. Jones in the SCAI press release. “Unlike any other TPV, this novel technology is designed to expand into the enlarged RVOT in these patients while simultaneously deploying a suitable bioprosthetic pulmonary valve. The Harmony TPV system has the potential to fundamentally alter the lifetime management of CHD patients from here on out.”