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

Claimed to be the smallest and long-lasting wireless MRI-compatible pacemaker, Assurity MRI enables wireless remote monitoring, allowing secure access to patients' diagnostic data and daily device measurements as well as decreases the need for in-office visits.

A pacemaker is a small, low-voltage implantable device developed to monitor the heart's rate and rhythm, and delivers electrical stimulation when the heart beats too slowly.

Abbott Cardiac Rhythm Management medical director 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."

The FDA approval now allows the patients implanted with these low-voltage devices to undergo full body magnetic resonance imaging (MRI) scans.

"The FDA approval now allows the patients implanted with these low-voltage devices to undergo full body magnetic resonance imaging (MRI) scans."

The Assurity MRI pacemaker works with Abbott's handheld MRI Activator device to activate pre-programmed MRI settings appropriately customised to individual patients.

This technology is expected to remove the effort, time and patient inconvenience associated with conventional pre- and post-scan pacemaker reprogramming.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The firm intends to further obtain approval for MR-conditional labeling from regulatory agencies in other countries, for its MRI-labeled products such as implanted pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy (CRT) devices.

Image: Abbott Assurity MRI Pacemaker. Photo: Courtesy of Abbott.