FDA approves revised labelling for Medtronic’s Evolut valve

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Medtronic has announced that the US Food and Drug Administration (FDA) has approved revised commercial labelling for the Evolut transcatheter aortic valve replacement (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 labelling 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 USA. The condition is an abnormality of the aortic valve resulting in the patient having two functional valve leaflets instead of the more common three leaflets (tricuspid).

“Clinical outcomes generated to date through the TVT Registry and the Low Risk Bicuspid Trial have shown that the Evolut TAVR system achieves favourable early results for patients with bicuspid aortic valve disease,” said John Forrest, associate professor of medicine at The Yale University School of Medicine, New Haven, USA. “The updated labelling 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 aortic stenosis.”

The revised labelling 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 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,” said Jeffrey Popma, chief medical officer and vice president, medical affairs for the Structural Heart business, which is part of the Cardiac and Vascular Group at Medtronic.


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