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Medtronic's Micra TPS Miniature Pacemaker Gets FDA Nod

It’s raining good news for Medtronic plc MDT, particularly in its Cardiac & Vascular business group. Following Medtronic’s recently announced 3-year positive study data announced in favor of Medtronic’s CoreValve system, the medical technology giant has reported the U.S. FDA approval to market its Micra Transcatheter Pacing system (TPS).

What is more commendable is that the regulatory approval for Micra TPS has come in earlier than the timeline originally expected by management in fiscal 2017. This implies an additional impetus for Medtronic’s Cardiac and Heart Rhythm business division.

Notably, Medtronic’s Micra TPS – the world’s smallest pacemaker – is the first ever product with miniaturized pacing technology to be awarded an FDA approval. This MRI-compatible device finds use amongpatients who need a single-chamber pacemaker.

Moreover, the device allows physicians to collect and send data of patients remotely via the Medtronic CareLink Network. The remote monitoring feature of Micra TPS is expected to be available later this year.

Medtronic received the aforementioned approval based on favorable results from the Micra TPS Global Clinical Trial, which was started in Dec 2013. This study aimed at evaluating the clinical safety and efficacy of Micra TPS.

In the final outcome, 96% of the patients experienced no major complications, which is significantly less than major complications witnessed in patients with conventional pacemakers. Such low major complication rates facilitates significant reduction in healthcare utilization for Micra patients, compared to those with standard pacemakers.

A quick review of past events will reveal that the Micra TPS first made it to the headlines in June 2014, when Medtronic announced successful preliminary results from the first human implant of this device. Thereafter, in Apr 2015, Medtronic won the CE Mark for the commercial launch of Micra TPS in the European markets, based on initial results for first 60 patients enrolled in the Micra TPS Global Clinical trial.

In May 2015, Medtronic revealed zero infection or dislodgment rates as well as mortality rates, with no unexpected serious adverse device events, for 140 patients as part of this trial. With this, Micra TPS duly met the initial safety and performance measures in its global clinical trial.

The latest commercial approval for Micra TPS in the U.S. is reflective of Medtronic’s commitment toward the continuous size reduction of its existing medical devices as well as the development of new ones. Currently, Medtronic is involved in bringing the Micra TPS to the Japanese market.

With the global geriatric population currently on rise, with U.S. at the forefront and Japan and Germany following suit, the demand for pacemakers are expected to rise significantly over time. This in turn implies an increased customer base for pacemaker manufacturers like Medtronic. Micra TPS’ leadless feature allowing for lesser complications in patients is an added bonus.

At present, the global pacemaker market is expected to reach $12.85 billion by 2020. We believe given the aforementioned developments, Medtronic will be able to capture a larger share of this market opportunity, going forward.

Medtronic currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the medical sector are LeMaitre Vascular, Inc. LMAT, Orthofix International N.V. OFIX and Baxter International Inc. BAX. While LeMaitre Vascular and Orthofix sport a Zacks Rank #1 (Strong Buy), Baxter holds a Zacks Rank #2.

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