U.S. FDA Approval for Abbott Assurity MRI™ Pacemaker

Abbott has announced U.S. 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.

Background

The story here is that pacemakers and other implantable cardiac devices have been gradually assuming MR-conditionality over the past few years. Pacemakers that allow patients to undergo MRI scans have become an important advancement, offering the possibility of MRI scans for patients who would hitherto been unable to have this diagnostic test without risking damage to their implant.

It’s not a straightforward matter of ignoring the existence of the pacemaker and getting on with the scan though. The usual routine involves effort, time and patient inconvenience to reprogramme the device, pre- and post-scan. In contrast, Abbott’s Assurity MRI pacemaker works with the company’s MRI Activator™ handheld device to trigger pre-programmed MRI settings appropriately tailored to individual patients.

The Assurity MRI pacemaker also offers wireless remote monitoring, providing physicians secure access to their patients’ diagnostic data and daily device measurements and reducing the need for in-office visits. Remote monitoring of cardiac patients has become a best practice over the past decade, and studies have continued to prove its positive impact on patient outcomes and the reduction of health care costs. In 2015, the Heart Rhythm Society made wireless remote monitoring the standard of care in its guidelines.

Abbott has continued to build its portfolio of MRI-labeled products, and continues to work with regulatory agencies around the world to secure approval for MR-conditional labeling for many of its most commonly implanted pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices.

Physician comments

“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,” said David Sandler, M.D., director of electrophysiology at the Oklahoma Heart Institute in Tulsa, Okla. “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.”

Company comments

“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,” said Avi Fischer, M.D., medical director for Abbott’s Cardiac Rhythm Management business.

Source: PR Newswire

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