Medtronic Evolut TAVR System Receives Updated U.S. Labeling Revising Precaution for Treatment of Low-Risk Patients with Bicuspid Aortic Stenosis
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 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.
- Bicuspid aortic valve disease is a congenital heart defect that is prevalent in 1-2% of the population and accounts for nearly half of all severe symptomatic aortic stenosis patients in the U.S.
- 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.