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FDA approves MR-conditional labeling for small pacemaker
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Abbott announced that the FDA has approved labeling granting MR-conditional status to a low-voltage pacemaker and pacing lead.
The pacemaker (Assurity MRI) is now the smallest in the world with MR-conditional labeling, according to a press release issued by the company.
The pacemaker and lead (Tendril) are indicated for patients who require cardiac pacing and may need to undergo MRI scans.
"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," David Sandler, MD, director of electrophysiology at the Oklahoma Heart Institute, Tulsa, said in the release. "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."
When a patient with the pacemaker undergoes an MRI scan, a handheld device (MRI Activator) is used to activate pre-programmed MRI settings tailored to the individual patient, according to the release.
The pacemaker allows for physicians to access a patient’s diagnostic data, as well as perform daily device measurements through remote monitoring, the company stated in the release.
Disclosure: Cardiology Today was unable to confirm relevant financial disclosures.