US FDA approves Assurity MRI pacemaker


Abbott has announced US Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labelling for both the Assurity MRI pacemaker and the Tendril MRI pacing lead.

Patients implanted with these low-voltage devices will have the ability to undergo full body magnetic resonance imaging (MRI) scans, if required. With the approval, the company states, the Assurity MRI pacemaker is now the world’s smallest, longest-lasting wireless MRI-compatible pacemaker.

The Assurity MRI pacemaker works with Abbott’s MRI Activator handheld device to trigger pre-programmed MRI settings appropriately tailored to individual patients. This technology can help eliminate the effort, time and patient inconvenience commonly associated with conventional pre- and post-scan pacemaker reprogramming.

“A long-lasting and small wireless pacemaker that allows patients to undergo MRI scans is an important step forward in growing our available treatment options for patients,” says David Sandler, director of electrophysiology at the Oklahoma Heart Institute in Tulsa, USA.