Medtronic has received the US Food and Drug Administration (FDA) approval for the revised commercial labeling for its Evolut TAVR platform to treat bicuspid severe aortic stenosis (AS) patients.
The approval has been given to a modification to a precaution for the treatment of such patients at a low risk of mortality during surgical aortic valve replacement
The revised commercial labelling includes recommendations for assessing TAVR as a potential treatment option for bicuspid patients, considering anatomical characteristics, age, long term durability, and the existing clinical data of the patients.
Bicuspid aortic valve disease is a congenital heart disorder, characterised by abnormality of the aortic valve resulting in the patient having two functional valve leaflets instead of the more common three leaflets (tricuspid).
The Yale University School of Medicine associate professor of medicine John Forrest said: “Clinical outcomes generated to date through the TVT 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.
“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 aortic stenosis.”
Low Risk Bicuspid Study supported the label expansion for Evolut TAVR system
The Evolut TAVR platform includes the Evolut R, Evolut PRO and Evolut PRO+ TAVR Systems. The platform is indicated for symptomatic severe AS patients across all risk categories in the US.
The revised labelling is supported by recent data from the Low Risk Bicuspid Study, which demonstrated that the bicuspid patients implanted with Evolut TAVR experienced reduced rates of mortality or disabling stroke at 30 days.
Also, the patients implanted with the company’s TVAR had low rate of serious procedural complications, annular ruptures or aortic dissections and no paravalvular leak.
The study also maintained the Evolut TAVR platform’s hemodynamics with patients experiencing low mean AV gradients, and large effective orifice area.
Medtronic chief medical officer and structural heart business medical affairs vice president Jeffrey Popma said: “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.”
In June, the company secured CE mark approval for its Evolut transcatheter aortic valve implantation (TAVI) system to treat patients with severe native aortic stenosis who are at low risk of surgical mortality.
