FDA Approves New MRI-Compatible Pacemaker

Abbott announced that the Food and Drug Administration (FDA) has approved the MRI-compatible Assurity MRI pacemaker, as well as the Tendril MRI pacing lead. 

Patients implanted with these devices have the ability to undergo full magnetic resonance imaging (MRI) scans if they are needed. The Assurity MRI pacemaker provides wireless remote monitoring, allowing physicians to access their patients’ diagnostic data and daily device measurements. This approval currently makes the Assurity MRI pacemaker the smallest, longest-lasting wireless MRI-compatible pacemaker.   

During an MRI scan, the low-voltage Assurity pacemaker works in conjunction with Abbott’s MRI Activator handheld device to trigger pre-programmed MRI settings that are customized to each patient. This capability reduces the effort, time, and patient inconvenience that comes with conventional pre- and post-scan pacemaker reprogramming. 

The Tendril MRI pacing lead along with the 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,” said Avi Fischer, MD, medical director for Abbott’s Cardiac Rhythm Management business.

For more information visit Abbott.com.