Medtronic valve for heart defects works well a year later: study

By Ransdell Pierson and Bill Berkrot WASHINGTON (Reuters) – A non-surgically implanted heart valve meant to delay open heart surgery in children with congenital heart defects worked well for all but a few patients during a year of follow-up observation, in line with favorable results seen in original clinical trials of the Medtronic Inc product. The Melody transcatheter pulmonary valve was approved in 2010 under a U.S. humanitarian device exemption, which allowed it on the market as long as a follow-up study was conducted to assess the product’s reliability and safety. “The valves had excellent function during the first year, judged by no more than mild leakage and very few patients had narrowing of the valve,” said Dr. Aimee Armstrong of the University of Michigan C.S. Mott Children’s Hospital Cardiac Catheterization Laboratories, who was lead investigator for the follow-up study sponsored by Medtronic. Within the first year of the study, eight adverse events were seen, including three cases of heart infections, two abnormal heart rhythms and one case each of bacterial infection, major stent fracture and blood clot in the lung.