The FDA approved MRI-conditional labeling for Abbott’s tiny wireless pacemaker, making it the smallest and longest-lasting MRI-compatible device of its kind. The new labeling also applies to a pacing lead.
The company picked up the Assurity MRI pacemaker and the Tendril MRI pacing lead in its acquisition of St. Jude Medical, which closed earlier this month. The pacemaker allows physicians to wirelessly monitor their patients, which can reduce the need for office visits, Abbott said in a statement. The Assurity pacemaker allows remote access to diagnostic data and daily device measurements using wireless radiofrequency (RF) telemetry.
The new labeling means that patients implanted with these devices may now undergo diagnostic MRI scans without fear of damaging their implant. During an MRI procedure, a hand-held device is used to activate preprogrammed MRI settings for the implants. These settings are individualized to each patient and can help cut down on the effort, time and inconvenience linked to traditional pre- and postscan pacemaker reprogramming, Abbott said.
"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," said Dr. David Sandler, director of electrophysiology at the Oklahoma Heart Institute in Tulsa, in the statement. "The ability to choose a device to best address a patient's cardiac condition no longer has a tradeoff with MRI compatibility. It's the best of both worlds."
Earlier this month, an FDA safety communication identified patients with RF-enabled St. Jude Medical implanted cardiac devices and a corresponding [email protected] device—which transmits device data to St. Jude’s Merlin patient care network—to be at risk of harm from “cybersecurity vulnerabilities.”