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February 2, 2017

Abbott secures FDA approval for Assurity MRI pacemaker

Healthcare firm Abbott has secured the US Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labelling of its Assurity MRI pacemaker and Tendril MRI pacing lead.

Healthcare firm Abbott has secured the US Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labelling of its Assurity MRI pacemaker and Tendril MRI pacing lead.

Claimed to be the smallest and long-lasting wireless MRI-compatible pacemaker, Assurity MRI enables wireless remote monitoring, allowing secure access to patients' diagnostic data and daily device measurements as well as decreases the need for in-office visits.

A pacemaker is a small, low-voltage implantable device developed to monitor the heart's rate and rhythm, and delivers electrical stimulation when the heart beats too slowly.

Abbott Cardiac Rhythm Management medical director Avi Fischer said: "Our proven Tendril MRI pacing lead-which has been implanted in more than 200,000 patients worldwide, along with the latest approved MR-conditional labeling for our Assurity MRI pacemaker, will help provide patients access to diagnostic procedures while delivering the product performance physicians need to provide the best possible care to their patients."

The FDA approval now allows the patients implanted with these low-voltage devices to undergo full body magnetic resonance imaging (MRI) scans.

"The FDA approval now allows the patients implanted with these low-voltage devices to undergo full body magnetic resonance imaging (MRI) scans."

The Assurity MRI pacemaker works with Abbott's handheld MRI Activator device to activate pre-programmed MRI settings appropriately customised to individual patients.

This technology is expected to remove the effort, time and patient inconvenience associated with conventional pre- and post-scan pacemaker reprogramming.

The firm intends to further obtain approval for MR-conditional labeling from regulatory agencies in other countries, for its MRI-labeled products such as implanted pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy (CRT) devices.


Image: Abbott Assurity MRI Pacemaker. Photo: Courtesy of Abbott.

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