The Assurity MRI (pictured above) and the Endurity MRI pacemakers make up St. Jude Medical's low-voltage MRI offering. A U.S. launch, anticipated in the first half of 2016, should help St. Jude Medical compete in the marketplace, as the company's main competitors either already offer a MRI-conditional pacemaker in the United States or are expected to enter the arena soon.
The Assurity MRI and Endurity MRI pacemakers received CE Mark in May 2015. Company management had originally expected to be able to launch the MRI pacemakers in the United States in the second half of 2015, but according to a Seeking Alpha transcript of the company's third quarter 2015 earnings call, then-CEO Daniel Starks explained, "We were expecting to receive FDA approval for our low-voltage MRI products here in the third quarter of 2015, and we didn't get it, and instead we got another round of questions. So we have a couple of quarter delays."
These products do not have U.S. FDA regulatory clearance or approval as of January 22, 2016.
[Assurity MRI, Endurity MRI and St. Jude Medical are trademarks of St. Jude Medical, Inc. or its related companies. Reprinted with permission of St. Jude Medical, ©2016. All rights reserved.]
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