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FDA OKs Medtronic's Evolut TAVR New Indication for Low Risk

Medtronic plc’s 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.

The data showed that TAVR has a superiorsafety profile and can be an effective treatment option in low-risk patients with shorter hospital stays. It also provides improved quality-of-life scores compared with the condition post open-heart surgical valve replacement (SAVR).

Huge Market Prospects

Per Medtronic, severe AS affects approximately 165,000 low-risk patients per year in the United States, Western Europe and Japan. It occurs when the aortic valve becomes diseased (stenotic). If left untreated, patients with severe aortic stenosis can die from heart failure  barely within a couple of years. We expect this new indication to capture the market of low-risk patients effectively.

Zacks Rank and Other Key Picks

Medtronic currently carries a Zacks Rank # 2 (Buy). A few other top-ranked stocks in the broader medical space are DENTSPLY SIRONA XRAY, Baxter BAX and Abbott Laboratories ABT, each holding the same top Zacks Rank as Medtronic. You can see the complete list of today’s Zacks #1 Rank (Strong Buy)  stocks here.

DENTSPLY’s long-term earnings growth rate is expected to be 11.5%.

Baxter’s long-term earnings growth rate is projected at 12.8%.

Abbott’s long-term earnings growth rate is expected to be 10.9%.

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