Results were presented at the Society for Cardiovascular Angiography and Interventions 41st annual scientific sessions, the Fridley, Minn.-based company said.
“Following the one-year feasibility outcomes, we are encouraged to see the Harmony valve continues to show positive outcomes for patients two years post-implant. We are optimistic that these early outcomes will be a strong indicator of the types of results that we might expect to see from our pivotal study, which is currently enrolling,” Dr. Matthew Gillespie of the Cardiac Center at Children’s Hospital of Philadelphia, who presented the results, said in a press release.
Medtronic’s Harmony TPV is designed as an alternative treatment for patients with Congenital Heart Disease, and was being examined in the study in CHD patients born with right ventricular outflow tract anomalies who underwent surgical repairs early in life. The study followed 18 patients out to two years, the company said.
Results at two years were consistent with one-year outcomes that the company presented in 2016, with patients followed to two-years showing continued strong hemodynamics. A total of 86.7% of patients reported trace or no pulmonary regurgitation, with mean gradients consistent and stable at two years. No paravalvular leaks were reported.
Two patients in the trial experienced tissue growth within the stent frame and were treated with a transcatheter valve-in-valve procedure with the company’s Melody TPV, Medtronic said.
“It’s important that these patients have access to a less invasive non-surgical option, and the Harmony TPV is uniquely designed to adapt to a wide variety of patient anatomies. Medtronic remains committed to congenital heart disease and we continue to look for ways to expand therapeutic options and improve outcomes for these patients, from their first surgeries as young children through their years as active, high-functioning adults,” Medtronic structural heart biz chief medical officer Dr. Pieter Kappetein said in a prepared statement.
A pivotal trial of the Harmony device is currently examining the device in 40 patients at 15 sites in the US, Canada and Japan, Medtronic said.
Earlier this month, Medtronic said it launched its OptiSphere embolization spheres designed for embolization of hypervascular tumors.