The approval covers the Ellipse ICD and its Tendril MRI pacing lead and Durata and Optisure high voltage leads. The new labeling opens up MRI scans as a diagnostic option for patients with abnormal heart rhythms who need treatment with an ICD.
The Ellipse ICD is indicated for patients with ventricular tachycardia. Caused by misfiring electrical signals, the heart beats abnormally quickly and becomes unable to effectively pump blood. ICDs monitor a patient's heart rate and deliver impulses when an abnormal rhythm is detected. If this isn't enough, the device "shocks" the heart to restore rhythm.
"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, M.D., chief medical officer for Abbott's Cardiac Arrhythmias and Heart Failure unit. "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."
Earlier this year, Abbott had MRI-conditional labeling approved for its Assurity pacemaker, also gained in the St. Jude deal. The Assurity device is the smallest and longest-lasting MRI-compatible device of its kind. Before the acquisition, St. Jude had notched a series of MRI-conditional labels for its devices, including its Proclaim and Protégé spinal cord stimulation systems.