August 21, 2020

FDA Approves Revised Labeling for Medtronic Evolut TAVR System

August 21, 2020—Medtronic announced that the FDA has approved revised commercial labeling for the Evolut transcatheter aortic valve replacement (TAVR) platform. The revised labeling modifies a precaution for the treatment of bicuspid severe aortic stenosis (AS) patients who are at low risk of mortality during surgical aortic valve replacement.

According to Medtronic, the revised commercial labeling includes recommendations that heart teams should consider when assessing TAVR as a potential treatment option for bicuspid patients, including patients’ anatomic characteristics, age, long-term durability, and the existing clinical data.

“Clinical outcomes generated to date through the [Transcatheter Valve Therapy] registry and the Low-Risk Bicuspid trial have shown that the Evolut TAVR system achieves favorable early results for patients with bicuspid aortic valve disease,” commented John Forrest, MD, in Medtronic’s press release. Dr. Forrest, who is Associate Professor of Medicine at Yale University School of Medicine in New Haven, Connecticut, continued, “The updated labeling is indicative of the progress that has been made to find minimally invasive treatment options for this particular group of patients with severe AS and should be part of the decision process made by heart teams evaluating patients with bicuspid AS.”

The company stated that the revised labeling is supported by recent data from the Low-Risk Bicuspid study, which showed that 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 hemodynamics with patients experiencing low mean aortic valve 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, which includes 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 United States. In addition, bicuspid aortic valve patients across all risk categories may be candidates for TAVR in the United States, advised Medtronic.


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