Abbott Laboratories acquired St. Jude Medical earlier this year knowing that the company trailed behind its peers in the cardiac rhythm management (CRM) space by not having a MRI-compatible pacemaker or implantable cardioverter defibrillator (ICD) system. It seems Abbott has officially caught up in that category though, first with FDA approval of the Assurity MRI pacemaker and the Tendril MRI pacing lead during the first quarter, and now with FDA approval of MRI-conditional labeling for the Ellipse ICD system.
Abbott said the recent approval covers one of its most widely-used ICD systems and associated high voltage leads. The approval is for the Ellipse ICD with the Tendril MRI pacing lead and Durata and Optisure high voltage leads.
The new labeling allows patients with an Ellipse ICD patients to undergo an MRI scan if needed.
“When you consider the number of patients each year who rely on the lifesaving treatment delivered by an ICD device, it is critical to continually innovate to provide new benefits to people battling complex arrhythmias and other cardiac conditions,” said Mark Carlson, MD, chief medical officer for Abbott’s cardiac arrhythmias and heart failure division. “By expanding our portfolio of MRI compatible devices, we’re adding another benefit onto an ICD device that was designed hand-in-hand with physicians to optimize therapy for patients.”