Medtronic releases early feasibility data on Harmony pulmonary valve
The Harmony device, which is based on the Melody valve shown above, is slated for an investigational device exemption trial late this year after the 6-month data revealed at ACC 2016. The 5-year, 20-patient feasibility study showed that severe pulmonary regurgitation improved from 95% to 0% after half a year, Fridley, Minn.-based Medtronic said.
“We are very encouraged by the positive early outcomes with the Harmony TPV. We look forward to partnering closely with the FDA to further continue our research with leading physicians to address an unmet need for this specific patient population,” vice president Rhonda Robb said in prepared remarks. “This clinical milestone underscores our commitment to broadening our congenital heart disease program as we bring new treatment solutions to this underserved patient group.”
“Through precise patient selection, the early feasibility data enables the clinical community to gather several key insights that will help to determine the valve’s therapeutic benefits in this patient population,” added Dr. John Cheatham of Columbus, Ohio’s Nationwide Children’s Hospital, who presented the data at ACC. “Due to its unique design and ability to adapt to a wide variety of patient anatomies, the Harmony TPV and its future iterations may provide a broad range of CHD patients with a minimally invasive treatment option that allows for shorter procedural time and hospital stay.” Read more