Abbott Laboratories (NYSE:ABT) Pacemakers Get FDA Approval

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Abbott Laboratories (NYSE:ABT) Pacemakers Get FDA Approval

The Tendril MRI pacing lead and the Assurity MRI pacemaker have been approved by the U.S. Food and Drug Administration. This will make it possible for individuals implanted with these low-voltage devices from Abbott Laboratories (NYSE:ABT) to undergo full body MRI scans if it becomes necessary.

“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,” the director of electrophysiology at the Oklahoma Heart Institute, David Sandler, said.

Remote wireless monitoring

The approval has made the Assurity MRI pacemaker the smallest and longest-lasting MRI-compatible pacemaker in the world that is wireless. With the Assurity MRI pacemaker, remote monitoring can now be done wirelessly. This makes it possible for physicians to get secure access to the diagnostic data of their patients. The physicians are also able to get daily device measurements which consequently reduces the need for physical visits to the office by the patient.

Use of remote monitoring for patients of cardiac disorders has become a best practice in the last ten years with studies continuing to show that it reduces the costs of health care and that it has a positive impact on patient outcomes. Wireless remote monitoring was made the standard of care in the guidelines issued by the Heart Rhythm Society in 2015.

Customized MRI settings

The use of pacemakers that allow MRI scans on those implanted with them has increasingly become popular for individuals who may require an MRI scan but do not want to risk causing damage to their heart device. In the course of an MRI scan, the Assurity MRI pacemaker is paired with the MRI Activator handheld device from Abbott in order to get the MRI settings that are customized for that particular patient. The technology can therefore save on time and effort and also avoid inconveniencing the patient when compared to the conventional devices that require pre-scan and post-scan pacemaker reprogramming.

Besides the FDA, Abott continues to collaborate with other regulatory agencies around the globe in order to get its products approved.

In Wednesday’s trading, shares of Abbott Laboratories rose by 1.34 percent to close the day at $42.33.