Abbott receives MR-conditional labeling approval for Ellipse ICD
Abbott Laboratories received the U.S. Food and Drug Administration (FDA)’s approval for magnetic resonance (MR)-conditional labeling for its Ellipse implantable cardioverter defibrillators (ICD).
The Ellipse ICD was part of Abbott’s $25 billion acquisition of St. Jude Medical, which was completed earlier in 2017. Ellipse ICD is meant to monitor heart rates for patients with ventricular tachycardia, or unusually fast heart rhythms. ICDs supply electricity to the heart to obtain the heart’s natural rhythm.
The approval of MR-conditional labeling for the Ellipse ICD with the Tendril MRI pacing lead and Durata and Optisure high voltage leads will help further improve access for patients who use an ICD because of fast heart rhythms and who may need an MRI scan in the future.
"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."
Earlier this year, Abbott’s Assurity pacemaker and Tendril MRI pacing lead were approved by the FDA for MR-conditional labeling.
As a senior news writer for TriMed, Subrata covers cardiology, clinical innovation and healthcare business. She has a master’s degree in communication management and 12 years of experience in journalism and public relations.