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Medtronic's Evolut TAVR System Shows Positive Study Results

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Medtronic plc MDT announced late-breaking clinical data from the Low Risk Bicuspid Study, which assessed the use of the Evolut transcatheter aortic valve replacement (TAVR) system in patients with bicuspid aortic valve stenosis at low surgical risks. The study was presented as part of the American College of Cardiology along with the World Congress of Cardiology Scientific Sessions meeting.

The study, which covered 150 patients, demonstrated low rates of all-cause mortality or stroke at 30 days, with a lower rate of serious procedural complications and no annular rupture or aortic dissection. Notably, the study delivered a significantly higher device success rate along with other favorable outcomes.

With the favorable study outcomes, Medtronic aims to strengthen its Coronary & Structural Heart segment globally. Notably, the Coronary & Structural Heart segment is part of the company’s broader Cardiac and Vascular Group.


Significance of the Favorable Outcome

Per a member of the medical fraternity associated with the study, the favorable study outcome presents an option of less invasive treatment for patients who otherwise had to go for open-heart surgery due to their anatomical valve structure. The study results also point that the Evolut TAVR platform is a suitable treatment option for patients with bicuspid valves, who were previously not included in TAVR trials.

Bicuspid aortic valve disease (BAVD) is a congenital heart defect, affecting approximately two percent of the general population who were excluded from previous TAVR trials due to concerns like potential incomplete valve expansion and procedural issues. Notably, Medtronic received the FDA’s approval in 2018 for revised commercial labeling for the Evolut TAVR system. This removed the precaution for the treatment of bicuspid severe aortic stenosis patients perceived at intermediate or greater risk for surgical aortic valve replacement.

However, the Evolut TAVR system is not yet approved in any geography for use in patients with bicuspid aortic valve stenosis at low surgical risk.

Industry Prospects

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

Given the market potential, the favorable study outcome is expected to boost the company.

Recent Developments in Cardiac and Vascular Group

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

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 of Micra AV, which is the world’s smallest pacemaker with atrioventricular synchrony.

Price Performance

Shares of the company have gained 1.5% in the past year against the industry’s 17.3% decline.

Zacks Rank & Other Key Picks

Currently, Medtronic carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks from the broader medical space are ResMed Inc. RMD, QIAGEN N.V. QGEN and Haemonetics Corp. HAE.

ResMed has a projected long-term earnings growth rate of 14.4%. It currently carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

QIAGEN’s long-term earnings growth rate is estimated at 10%. The company presently has a Zacks Rank #2.

Haemonetics’ long-term earnings growth rate is estimated at 12%. It currently carries a Zacks Rank #2.

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