Credit: Shutterstock photoMedical technology giant Medtronic plcMDT recently released positive long-term results from the Micra Transcatheter Pacing System (TPS) Global Clinical Trial, successfully demonstrating the superiority of its Micra TPS over conventional pacemakers. Notably, the Micra TPS is the smallest available leadless pacemaker and has already achieved marketing approval in the U.S. as well as overseas.
With increasing prevalence of pacemaker implementation worldwide and the less invasive alternative that Medtronic's Micra TPS offers compared to the conventional systems, it is reasonable to expect that these trial results will induce a surge in global demand for pacemakers manufactured by Medtronic.
Micra TPS and the Trial Results
Comparable to the size of a large vitamin, Micra TPS is implanted in a patient via a minimally invasive approach and is positioned under the skin; thereby eliminating complications associated with conventional pacemakers like leads and need for surgical pockets for positioning. Notably, this device is approved for undergoing both 1.5 and 3 Tesla (T) full-body magnetic resonance imaging (MRI) scans.
At the 12-month trial results that Medtronic presented recently from the Micra TPS trial, at the 2016 European Society of Cardiology (ESC) Congress in Rome, Micra TPS successfully reduced the risk of major complications by nearly 50% compared to traditional pacemakers, across all patient sub-groups. In fact 96% of the patients implanted with a Micra TPS exhibited no major complications.
Micra TPS also successfully reduced the risk of patient hospitalization by 47% and risk of system revisions by 82%. Further, Micra battery projections continued to perform in-line with conventional pacemaker systems. Evidently, Micra yielded a projected average longevity of more than 12 years in patients who have used the device for 12 months.
Management remained particularly impressed with the consistent safety and efficacy Micra TPS exhibited so far in patients with diverse comorbidities. Notably the recent 12-month data came in line with the preliminary results Medtronic presented from this very trial in Nov 2015, wherein the Micra TPS was successfully implanted in 99.2% of patients and met its safety as well as effectiveness endpoints with wide margins.
Our View
Post receiving the FDA approval for its Micra TPS in Apr 2016, Medtronic has started shipping this product in the first quarter of fiscal 2017 in the U.S. Concurrently, management has initiated physician training in the U.S. and hopes to win a national coverage decision from CMS for this transformative therapy by the end of the fiscal 2017.
We believe the aforementioned long-term results from the Micra TPS trial will pave the way for the reimbursement coverage for this smallest pacemaker, which in turn should bolster the demand and subsequent revenues from Medtronic's Cardiac and vascular business group.
At present, the global pacemaker market is expected to reach $12.85 billion by 2023. Given the aforementioned developments, we expect Medtronic to capture a larger share of this market opportunity, going forward.
Stocks to Consider
Medtronic currently carries a Zacks Rank #3 (Hold). Some better-ranked medical stocks are Lantheus Holdings, Inc. LNTH , GW Pharmaceuticals plc GWPH and Quidel Corp. QDEL . All these stocks sport a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
