FDA Approves 34-mm TAVR Valve for Patients With Larger Anatomy
Physicians in the United States will now have the option to use a 34-mm device for TAVR procedures, following an approval on Wednesday by the US Food and Drug Administration. The new Evolut R 34-mm valve (Medtronic) is approved for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26-30 mm, a press release states.
Evolut R valves are recapturable and repositionable. According to the manufacturer, as many as 25-30% of all patients worldwide who are potentially eligible for TAVR have larger valve annulus sizes than what has previously been on the market in the United States, which is the only place the device is currently approved.
Medtronic. Medtronic announces FDA approval of new recaptureable TAVR system available for severe aortic stenosis patients with large anatomies. http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2216121. Published on: October 26, 2016. Accessed on: October 27, 2016.