Two-Year Results Presented From Feasibility Study of Medtronic's Harmony TPV
May 4, 2018—Medtronic announced that 2-year outcomes from the early feasibility study of the company's Harmony transcatheter pulmonary valve (TPV) were presented by Matthew J. Gillespie, MD, at the Society for Cardiovascular Angiography and Interventions (SCAI) scientific sessions, held April 25–28 in San Diego, California.
According to the company, the Harmony TPV showed solid valve function and no paravalvular leak in data from 18 patients who were followed out to 2 years.
Available for investigational use only, the Harmony TPV is being studied in congenital heart disease patients born with right ventricular outflow tract anomalies who undergo a surgical repair early in life. The Harmony pivotal investigational device exemption study is enrolling up to 40 patients at approximately 15 sites in the United States, Canada, and Japan.
At 2-year follow-up, patients demonstrated strong hemodynamics, with 86.7% of patients having no/trace pulmonary regurgitation, mean gradients were consistent and stable, and there were no paravalvular leaks reported. Two patients experienced tissue growth within the stent frame and were treated successfully with a transcatheter valve-in-valve procedure with the Melody TPV.
Medtronic noted that the findings are consistent with the 1-year outcomes presented at TCT 2016, the 28th annual Transcatheter Cardiovascular Therapeutics scientific symposium, which was held October 29 to November 2, 2016 in Washington, DC.
In Medtronic's announcement, Dr. Gillespie commented, "Following the 1-year feasibility outcomes, we are encouraged to see the Harmony valve continues to show positive outcomes for patients 2-years postimplant. 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."