FDA OKs Medtronic's Evolut TAVR New Indication For Low Risk
Zacks Investment Research | Aug 20, 2019 11:00PM ET
Medtronic plc’s (NYSE:MDT) Evolut Transcatheter Aortic Valve Replacement (TAVR) system has won the FDA’s approval for expanded indication to treat symptomatic severe native aortic stenosis in patients at a low risk of surgical mortality. This, in turn, opens the route to traditional open heart surgery’s minimally invasive alternative path for the younger patient set, who is more active than higher-risk patients. Undoubtedly, the latest indication will increase the patient base for Medtronic’s TAVR platform within its Cardiac and Vascular division.
With this nod, the Evolut TAVR platform is now indicated for symptomatic severe aortic stenosis (AS) patients across all risk categories (extreme, high, intermediate and low) in the United States.
What is Aortic Stenosis?
AS refers to a serious medical condition wherein one’s aortic valve narrows. It can cause cardiac arrest and even death, if left untreated. Aortic valve replacement is a standard procedure to treat such patients. However, those at risk of open-heart surgery can instead be treated with transcatheter heart valve (THV) implantation of a device like Evolut using a less-invasive procedure.
A Brief Note on the Evolut TAVR Approval
The expanded indication approval came on the back of a favorable clinical outcome from the global, prospective, multi-center Evolut Low Risk Trial, which evaluated three valve generations, namely CoreValve, Evolut R and Evolut PRO in more than 1,400 patients.
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