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FDA approves 'world's smallest' pacemaker for heart patients

Medtronic's Micra TPS is the first transcatheter pacemaker approved for use in the States.
Billy Steele
April 7, 2016
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As consumer technology has trended smaller and thinner, medical devices have done the same. And now, the first transcatheter pacemaker has been approved for use with heart patients in the US. Medtronic gained FDA approval for its Micra TPS pacemaker, the first device to employ the miniaturized pacing tech to be approved by the US government. The company is calling the device the "world's smallest pacemaker," measuring just a tenth of the size of traditional technology. It's about the size of large vitamin.

The Micra TPS attaches to the heart with small tines, delivering impulses with an electrode at one end. The device doesn't require a "pocket" under a patient's skin like traditional devices and it's completely concealed from view. What's more, this tiny pacemaker adjusts the impulse based on a patient's activity level automatically. It's also approved for use during full-body MRI scans, so patients will still have access to detailed medical imaging processes should the need arise.

During clinical trials, Medtronic says the Micra TPS was successfully implanted in over 99 percent of patients with no reported instances of it moving out of place. 96 percent patients didn't experience any complications either, 51 percent lower than the numbers for more traditional pacemakers. The company also notes that over 98 percent of patients exhibited "low and stable" pacing after six months, a rate at which the Micra TPS could last for more than 12 years.

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