Abbott (NYSE:ABT) said today that the FDA approved magnetic resonance-conditional labeling for its Assurity MRI pacemaker and its Tendril MRI pacing lead. The federal watchdog’s approval makes its Assurity device the world’s smallest, longest-lasting wireless MRI-compatible pacemaker, the company reported.
During an MRI scan, Abbott’s MRI Activator device triggers pre-programmed MRI settings for the Assurity pacemaker, eliminating the need for conventional pre- and post-scan pacemaker reprogramming.
“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,” Dr. David Sandler, director of electrophysiology at the Oklahoma Heart Institute, said in prepared remarks. “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.”
The Assurity pacemaker also features wireless remote monitoring so physicians can access their patients’ diagnostic data and daily measurements, lessening the need for frequent in-office visits, according to Abbott.
“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,” medical director of Abbot’s cardiac rhythm management biz Dr. Avi Fischer added.
EU regulators approved the union, contingent upon Abbott selling off some of Alere’s Epoc and Triage tests and its BNP reagents business. Abbott also plans to sell plants in Ottawa and San Diego to appease the commission.
Abbott sued last month to stop the merger, citing a “substantial loss in Alere’s value” and arguing that since signing the agreement a year ago, Alere “suffered a series of damaging business developments.”
Alere responded by saying that the filing is “entirely without merit.”