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FDA Nods to Medtronic's (MDT) New Age Evolut PRO+ TAVR

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Medtronic plc’s MDT Evolut PRO+, the next-generation Transcatheter Aortic Valve Replacement (TAVR) system, has won the FDA approval. The company also announced the commercial launch of this device, which is developed on the self-expanding, supra-annular Evolut TAVR platform.

The latest nod from the regulatory agency added just another feather in Medtronic’s Evolute cap. This feat follows the last month’s FDA nod for the Evolut TAVR system regarding its expanded indication to treat symptomatic severe native aortic stenosis in patients at a low risk of surgical mortality. Undoubtedly, the new indication will increase the patient base for Medtronic’s TAVR platform within its Cardiac and Vascular division.

What is Aortic Stenosis (AS)?

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 an open-heart surgery can instead be treated with transcatheter heart valve (THV) implantation device like Evolut using a less-invasive procedure.

A Brief Note on the Evolut PRO+

This system hasfour valve sizes (including one 34 mm) with an external pericardial tissue wrap to treat patients with a range of anatomical variations. Medtronic claims this to be a major breakthrough as earlier, the option of adding the external tissue wrap to the large 34mm valve size, was not available in the market.

This advanced version of Evolut TAVR provides better sealing for the largest indicated patient treatment range and the lowest delivery profile currently offered in the market. Medtronic noted that, “in addition to a decrease in profile for the core sizes to help minimize burden on the vessels during the procedure, the Evolut PRO+ TAVR System gives heart teams a familiar technology that’s been fine-tuned to help drive excellent patient outcomes.”

Huge Market Prospects

Severe AS 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.

Going by a recent Grand View Research report,the growing incidence of valvular diseases like AS and the increasing preference for minimally invasive surgeries are fuelling growth for the global aortic valve replacement devices market. Per data, this market — valued at $5.81 billion in 2017 — is going to witness a CAGR of 11.1% by 2025. We expect Medtronic’s innovation to capture the space effectively.

Share Price Performance

The company has rallied 12.7% in the past three months compared with the industry’s growth of 4%.

Zacks Rank & Other Key Picks

Currently, Medtronic carries a Zacks Rank #2 (Buy). Some other top-ranked stocks from the broader medical space are Capricor Therapeutics, Inc CAPR, GW Pharmaceuticals PLC GWPH and Neurotrope, Inc NTRP.

Capricor has a Zacks Rank #1 (Strong Buy) and a projected third-quarter 2019 earnings growth rate of 28.2%. You can see the complete list of today’s Zacks #1 Rank stocks here.

GW Pharmaceuticals estimates third-quarter earnings growth rate to be 72.8%. It currently sports a Zacks Rank of 1.

Neurotrope has a Zacks Rank of 2 and an expected third-quarter earnings growth rate of 27.7%.

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