Medtronic’s Micra TPS: Smallest Pacemaker to Win CE Mark

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Medical device major Medtronic plc’s MDT next generation leadless pacing technology – the Micra Transcatheter Pacing System (TPS) – recently won the CE (Conformité Européenne) Mark. With a size less than one tenth of that of conventional pacemakers, the Micra TPS is the smallest pacemaker till date and can be delivered directly into one’s heart through a catheter, utilizing minimally invasive procedures.

Bradycardia is a common medical condition involving slow or irregular heartbeat of individuals. Pacemaker therapy – the most common treatment for bradycardia – restores one’s heart’s rhythm by sending electrical signals to the heart.

Unlike conventional pacemakers, the Micra TPS does not need any leads (wires) or a surgical pocket under the skin, thereby eliminating the chance of any implantation-related complications. It is a cosmetically invisible device which once attached to the heart wall can be repositioned or retrieved, on demand.

This pacing technology responds to patients’ activity levels by automatically adjusting therapy. Despite its miniaturized size (similar to a large vitamin pill), the Micra TPS has an estimated 10-year battery life and is approved for full body MRI scans, provided patients have access to the most advanced imaging diagnostic procedures.

However, we take a note that the Micra device is useful for patients who benefit from single-chamber pacing as it paces one chamber of the heart – the right ventricle only.

Currently, Medtronic is conducting the single-arm, multi-center Medtronic Micra TPS Global Clinical Trial, which aims at estimating the clinical safety and efficacy of the Micra TPS. The Micra device received CE Mark based on initial results from the first 60 patients enrolled in this trial.

We look forward to the presentation of the initial results of this study which the company is likely to reveal at the Heart Rhythm Society’s 2015 Annual Scientific Sessions in May 2015.

The recognition of Micra TPS is reflective of Medtronic’s commitment toward the continuous size reduction of its existing medical devices as well as the development of new ones.

Medtronic’s pacemaker business had been delivering a sluggish performance over the past few years owing to several macroeconomic headwinds as well as competitive products launches. However, this business has returned to a positive growth trajectory in the past few quarters. Evidently, revenues from Medtronic’s Low Power business involving pacemaker systems grew 17% at CER in the last reported quarter.

We are also encouraged with the recent data which confirms the sustainability of this growth trend. The company revealed that each year over 1 million cardiac patients around the globe undergo pacemaker implantation. With the rise in aging population, this count is only expected to rise. We believe the CE Mark approval for the Micra pacemaker will allow Medtronic to cater to this huge number of patients. This in turn will fetch higher profits for the company.

Currently, the stock carries a Zacks Rank #3 (Hold). Some better-ranked medical products stocks are LeMaitre Vascular, Inc. LMAT, SurModics, Inc. SRDX and Cardiovascular Systems Inc. CSII. All the three stocks sport a Zacks Rank #1 (Strong Buy).

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