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Abbott gets FDA approval for MR conditional labeling of Assurity MRI pacemaker

MDBR Staff Writer Published 02 February 2017

Abbott has secured approval from the US Food and Drug Administration (FDA) for magnetic resonance (MR)-conditional labeling of Assurity MRI pacemaker and Tendril MRI pacing lead.

Patients with these low-voltage devices can undergo full body magnetic resonance imaging (MRI) scans, if necessary.

Assurity MRI pacemaker is claimed to be the world's smallest and longest-lasting wireless MRI-compatible pacemaker.

The pacemaker also provides wireless remote monitoring, enabling physicians to access their patients' diagnostic data and daily device measurements.

During an MRI scan, Assurity MRI pacemaker is said to work with Abbott's MRI Activator handheld device to activate pre-programmed MRI settings as per the requirements of individual patients.

A pacemaker is a small and low-voltage implantable device, which sends electrical pulses to the heart when it beats too slowly.

The company is working with regulatory agencies across the globe to secure approval for MR-conditional labeling for its products such as implanted pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices.

Abbott's cardiac rhythm management business medical director Dr Avi Fischer said: "Our proven Tendril MRI pacing lead — which has been implanted in more than 200,000 patients worldwide — along with the latest approved MR-conditional labeling for our Assurity MRI pacemaker, will help provide patients access to diagnostic procedures while delivering the product performance physicians need to provide the best possible care to their patients.”


Image: Abbott’s Assurity MRI pacemaker. Photo: courtesy of Abbott.