Medtronic (NYSE:MDT) said today that it’s launching a study of its CoreValve Evolut replacement heart valve in a low-risk patient population with a genetic form of heart disease, following a pair of FDA decisions about the treatment.
The Fridley, Minn.-based medtech titan said the FDA granted an investigational device exemption for a single-arm trial of the CoreValve Evolut transcatheter aortic valve replacement in low-risk patients born with two leaflets instead of three.
Separately, the federal safety watchdog revised the valve’s labeling to remove a warning about treatment of intermediate-or-greater-risk bicuspid patients, Medtronic said.
“As a leader in heart valve solutions, this label revision enables us to provide proactive training and education on procedural TAVR sizing and placement in this patient population,” structural heart medical affairs vice president Dr. Pieter Kappetein said in prepared remarks. “The bicuspid study, in addition to new studies on TAVR efficiencies and leaflet mobility, will provide important insights as we look to further refine TAVR therapy.”
“Real-world data suggests that TAVR with the self-expanding Evolut can be a suitable treatment option for many patients with bicuspid aortic valve disease,” added Dr. Jeffrey Popma of Boston’s Beth Israel Deaconess Medical Center. “In fact, data from the TVT Registry has shown near-parity in certain outcomes between bicuspid and tricuspid patients using the Evolut self-expanding platform.”