Medtronic Harmony TPV Clinical and Hemodynamic Outcomes Evaluated at 2 Years

May 20, 2023—Medtronic announced 2-year results from an analysis of the company’s Harmony transcatheter pulmonary valve (TPV) system, which treats severe pulmonary regurgitation (PR) in the native or surgically repaired right ventricular outflow tract (RVOT). The company stated that the analysis demonstrated strong clinical and hemodynamic outcomes for patients with a congenital heart defect of the RVOT.

The findings were presented at the SCAI 2023 Scientific Sessions held May 18-20 in Phoenix, Arizona.

According to the company, patients received a commercially available Harmony valve—22 mm (TPV22 device) or 25 mm (TPV25 device)—as part of the Harmony Native Outflow Tract early feasibility study, Harmony TPV pivotal trial, and Continued Access study. Eligible patients had severe PR by echocardiography or PR fraction ≥ 30% by cardiac MRI and a clinical indication for pulmonary valve replacement.

The pooled analysis was composed of 86 patients who were implanted with a TPV22 (n = 42) or TPV25 (n = 44) device, all of whom remained implanted for > 24 hours. Key findings included 0% vascular injury requiring intervention, 99% freedom from major stent fracture, and 99% with no/trace PR at 2 years.

“Sharing these longer-term outcomes for the Harmony transcatheter valve is an important milestone to help offer more streamlined treatment options for patients living with congenital heart disease,” commented Mary Hunt Martin, MD, in the company’s press release. “The strong safety profile reflected in these findings is especially encouraging since prior to Harmony, many of these patients would have to undergo multiple surgeries early on in their life.” Dr. Martin is Director of Adult Congenital Intervention at University of Utah and Primary Children’s Hospital in Salt Lake City, Utah.

Medtronic advised that the Harmony TPV system received FDA approval in 2021 based on the Harmony TPV clinical study that demonstrated the device’s safety and effectiveness.

The Harmony TPV device is commercially available for use in the United States and Japan, and it has received regulatory approval in Canada and Saudi Arabia. In February 2023, the company announced it relaunched the Harmony TPV system after a voluntary recall of the Harmony delivery catheter system in March 2022. Medtronic worked with the FDA to remediate the issue and earn FDA approval to return the device to market, noted the company.