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Medtronic's (MDT) Evolut TAVR Label Expansion Gets FDA Nod

Medtronic plc’s MDT Evolut Transcatheter Aortic Valve Replacement (TAVR) system has won FDA approval for revised commercial labeling. This modification relates to certain precaution during surgical aortic valve replacement for the treatment of bicuspid severe aortic stenosis (AS) in patients at a low risk of mortality.

The revision in commercial labeling includes recommendations related to patients’ anatomical characteristics, age, long-term durability, and the existing clinical data while assessing TAVR as a potential treatment option for bicuspid patients. With the Evolut TAVR being widely adopted by a variety of patients including those who have unique anatomical variations, this label expansion is important for providing more accurate treatment option for AS.

This revised labeling is based on recent data from the low-risk bicuspid study. The study showed bicuspid patients implanted with Evolut TAVR had low rates (1.3%) of all-cause mortality or disabling stroke at 30 days along with a low rate of severe procedural complications, no annular ruptures or aortic dissections and no moderate/severe paravalvular leak.

What is Aortic Stenosis?

Aortic stenosis refers to a serious medical condition wherein one’s aortic valve narrows. It can cause cardiac arrest and even death, if left untreated. Going by Medline Plus’ definition, bicuspid aortic valve is an aortic valve that only has two leaflets, instead of three. This congenital defectdevelops during the early weeks of pregnancy, when the baby's heart is developing.

Aortic valve replacement is a standard procedure to treat AS 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.

Market Prospect

According to Medtronic, bicuspid aortic valve is seen in 1-2% of the U.S. population and accounts for nearly half of all severe symptomatic aortic stenosis patients.

Per a report by Mordor Intelligence, the cardiovascular devices market is expected to witness CAGR of 6.3% between 2019 and 2024. Factors like increasing incidence of cardiovascular diseases and growing geriatric population are expected to drive the market further.

We expect this revised labeling to capture the market of low-risk patients effectively.

Cardiac and Vascular Developments in 2020

Of late, Medtronic has been witnessing a series of developments in its business arm.

In June, Medtronic received CE Mark for Micra AV Transcatheter Pacing System (TPS), the world’s smallest pacemaker with atrioventricular (AV) synchrony. Micra AV is indicated for the treatment of patients with AV block, a condition in which the electrical signals between the chambers of the heart (the atria and the ventricle) are impaired. 

In the same month, the company announced the receipt of CE Mark for a one-month dual antiplatelet therapy indication for high bleeding risk patients implanted with the Resolute Onyx Drug-Eluting Stent.

In January, the company received the CE Mark for its "Cobalt and Crome" portfolio of implantable cardioverter-defibrillators and cardiac resynchronization therapy-defibrillators. Further, it received the FDA’s approval to proceed with an investigational device exemption trial to evaluate the safety and effectiveness of the PulseSelect Pulsed Field Ablation (PFA) System. Notably, the PFA is a new technology that uses pulsed electric fields to treat atrial fibrillation.

In the same month, Medtronic received the FDA’s approval for Micra AV, which is the world’s smallest pacemaker with atrioventricular synchrony.

Price Performance

Shares of the company have lost 7.7% in the past year compared with the industry’s 4.5% fall.

Zacks Rank & Key Picks

Currently, Medtronic carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are QIAGEN N.V. QGEN, Thermo Fisher Scientific Inc. TMO and Hologic, Inc. HOLX.

QIAGEN’s long-term earnings growth rate is estimated at 22.3%. It currently sports a Zacks Rank #1. (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Thermo Fisher’s long-term earnings growth rate is estimated at 15%. It currently carries a Zacks Rank #2 (Buy).

Hologic’s long-term earnings growth rate is estimated at 15.5%. The company presently sports a Zacks Rank #1.

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