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Medtronic (MDT) Releases Positive Study Results on Pacemaker

Zacks Equity Research

Medtronic plc MDT recently announced favorable data from its study on MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer). The study results demonstrate that an investigational set of algorithms in the Micra Transcatheter Pacing System (“TPS”) significantly improves synchrony and cardiac function in patients with impaired electrical conduction between the chambers of the heart, called atrioventricular (AV) block.

The company will present the results of MARVEL 2 on Nov 16 during a Featured Science session at American Heart Association 2019, the AHA Scientific Sessions.

Based on the favorable outcomes, Medtronic submitted a new leadless pacemaker (Micra AV) to the FDA for review, with an aim to expand the indicated population to AV block and normal sinus rhythm. With this, the company aims to strengthen foothold in the leadless pacemaker market on the back of the favorable outcome of the study.


A Closer Look at the Micra Portfolio

Per the company, the Micra TPS is the only leadless pacemaker approved for use by the FDA in the United States. The Micra TPS is much smaller in size compared to the traditional pacemakers, delivering the most advanced pacing technology to patients through a minimally invasive approach. The Micra is innovative as the TPS can be permanently switched off as per requirement.

Why is the Study a Breakthrough?

Per the company, the outcomes indicate that there will be an improvement in the coordination between the atrium and ventricle sections of the heart as a result of the upgraded to the Micra TPS. This improves outreach for patients, who are eligible to be treated with the leadless pacemaker.

The MARVEL 2 study assessed 75 patients worldwide with a Micra TPS, out of which 40 patients had complete heart block and normal sinus rhythm and were eligible for inclusion in the primary efficacy analysis. There were no abnormal occurrences in meeting the safety objective of the study — its primary endpoint.

Recent Developments

Of late, Medtronic has been witnessing a slew of innovation related to its cardiac and vascular business.

The company launched the Valiant Navion thoracic stent graft system in Japan for the minimally invasive repair of thoracic descending aortic aneurysms (TAA) and complicated type B aortic dissections (TBAD) in October. The Valiant Navion is an improvement to the already existing Valiant Captivia thoracic stent graft system. Again, in the same month, the company launched its advanced Patient Programmer technology for Deep Brain Stimulation (DBS) therapy, which allows patients to manage their therapy more simply and discreetly.

Further, in October, the company also received the Breakthrough Device designation from the FDA for Fully Implantable Left Ventricular Assist Device (LVAD) and Valiant thoracoabdominal aortic aneurysm (TAAA) stent graft system. The Fully Implantable LVAD is currently in the development stage and intended for patients with advanced heart failure. The Valiant TAAA stent graft system is to be used for minimally invasive repair of TAAA.

In September, Medtronic received FDA nod for Evolut PRO+ TAVR System, which is an innovative transcatheter aortic valve replacement (TAVR) system that builds off the proven self-expanding, supra-annular Evolut TAVR platform.

Industry Prospects

Per a report by ResearchAndMarkets, the global leadless cardiac pacemakers market is anticipated to reach $269.8 million by 2026 from $47.1 million in 2017, expanding at a CAGR of 21.9% from 2018 to 2026. The key factors driving the market are the growing incidents of patients suffering from atrial fibrillation and affordable reimbursement scenario.

Given the potential of the pacemaker market, the study outcome has come at the right time.

Price Performance

The company’s shares have gained 17.3% in the past year compared with the industry’s growth of 5%. Moreover, the S&P 500 index rallied 12.9% during the same period.

Zacks Rank & Other Key Picks

Currently, Medtronic carries a Zacks Rank #2 (Buy). Some other top-ranked stocks from the broader medical space are Haemonetics Corporation HAE, NuVasive, Inc NUVA and GW Pharmaceuticals plc GWPH.

Haemonetics, currently sporting a Zacks Rank #1 (Strong Buy), has a projected long-term earnings growth rate at 13.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.

NuVasive, with a Zacks Rank #2, has projected a long-term earnings growth rate of 10.9%.

GW Pharmaceuticals estimates fourth-quarter earnings growth rate at 67.9%. It currently carries a Zacks Rank #2.

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