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CRT defibrillator, ICD receive labeling approval from FDA
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Abbott announced that a cardiac resynchronization therapy defibrillator and an implantable cardioverter defibrillator to treat patients with potentially life-threatening heart rhythms and congestive HF have received magnetic resonance-conditional labeling from the FDA.
The CRT defibrillator (Quadra Assura MP, Abbott) allows the lower chamber of the heart to beat in rhythm while improving blood flow, whereas the ICD (Fortify Assura, Abbott) restores normal heart rhythms, according to a press release from the company.
These magnetic resonance conditional labeling approvals follow recent labeling approvals of a pacemaker (Ellipse, Abbott) and other compatible leads.
“For many patients who need an ICD or CRT-D device, receiving a device that is MRI-ready is a key benefit that can ensure future access to MRIs — an important and commonly used diagnostic tool,” Avi Fischer, MD, divisional vice president of medical affairs and medical director of the cardiac rhythm management business for Abbott, said in the press release.
Disclosure: Fischer is an employee of Abbott.