August 21, 2020 – Medtronic plc (Dublin, Ireland) announced that the U.S. Food and Drug Administration (FDA) has approved revised commercial labeling for the Evolut TAVR platform that modified a precaution for the treatment of bicuspid severe aortic stenosis (AS) patients at a low risk of mortality during surgical aortic valve replacement.
The revised commercial labeling includes recommendations heart teams should consider when assessing TAVR as a potential treatment option for bicuspid patients, including patients’ anatomical characteristics, age, long term durability, and the existing clinical data.
The company says that the revised labeling is supported by recent data from the Low Risk Bicuspid Study, which showed bicuspid patients implanted with Evolut TAVR had low rates of all-cause mortality or disabling stroke at 30 days (1.3%), a low rate of serious procedural complications, no annular ruptures or aortic dissections and no moderate/severe paravalvular leak.
The study also maintained the Evolut TAVR platform’s industry-leading hemodynamics (blood flow) with patients experiencing low mean AV gradients (7.6 ± 3.7 mm Hg), and large effective orifice area (2.3 ± 0.7 cm2). The pacemaker rate was 15.1%.
The Evolut TAVR platform – including the Evolut R, Evolut PRO and Evolut PRO+ TAVR Systems – is indicated for symptomatic severe AS patients across all risk categories (extreme, high, intermediate and low) in the U.S. In addition, bicuspid aortic valve patients across all risk categories may be candidates for TAVR in the U.S.