Abbott announced that it has received US Food and Drug Administration (FDA) approval for Magnetic Resonance (MR)-conditional labeling for both the Assurity MRI™ pacemaker and the Tendril™ MRI pacing lead.
With the approval, the Assurity MRI pacemaker is now the world's smallest, longest-lasting wireless MRI-compatible pacemaker.
Patients implanted with these low-voltage devices will have the capability to undergo full body Magnetic Resonance Imaging (MRI) scans, if required.
Physicians can securely access their patients' diagnostic data and daily device measurements using the Assurity MRI pacemaker. It also helps to reduce the need for in-office visits.
The Assurity MRI™ pacemaker has become an important advancement for patients who need an MRI in the future.
In addition, the Assurity MRI pacemaker works with Abbott's MRI Activator™ handheld device to trigger pre-programmed MRI settings that are tailored to individual patients during an MRI scan.
It helps to reduce the effort, time and patient’s inconvenience that is associated with conventional pre- and post-scan pacemaker reprogramming.
Assurity MRI pacemaker that allows patients to undergo MRI Scans plays a key role in growing treatment options for patients.
Tendril MRI will help to provide patients access to diagnostic procedures while delivering the product performance physicians need to provide the best possible care to their patients.