Medtronic (NYSE:MDT) announced last week that it received FDA approval for revised commercial labeling on its Evolut TAVR platform.
Fridley, Minn.-based Medtronic said in a news release that the revised labeling modified a precaution for the treatment of bicuspid severe aortic stenosis (AS) patients who are at low risk of mortality during surgical transcatheter aortic valve replacement (TAVR).
The revised labeling offers recommendations that heart teams should consider when assessing TAVR as a potential treatment option for bicuspid patients, with concepts such as anatomical characteristics, age, long-term durability and existing clinical data to be considered.
Recent data from a study supported the revised labeling after bicuspid patients implanted with Evolut TAVR had low rates of all-cause mortality or disabling stroke at 30 days, a low rate of serious procedural complications, no annular ruptures or aortic dissections and no moderate/severe paravalvular leak.
“The increased adoption of the Evolut platform globally is partially attributed to the fact that it meets the needs of a broad variety of patients including those who have unique anatomical variations,” Medtronic chief medical officer & VP of medical affairs for the structural heart business Dr. Jeffrey Popma said in the release.