St. Jude Medical (NYSE:STJ) said it received expanded CE Mark approval for its high-voltage Ellipse implantable cardioverter defibrillator. St. Jude won FDA approval and initial CE Mark approval for the device in 2012.
The expanded labeling marks the Ellipse ICD as safe for use in conjunction with magnetic resonance imaging, St. Paul, Minn.-based St. Jude said. The company said it also received expanded CE Mark approval for its Assurity MRI and Endurity MRI pacemakers.
The expanded approval also includes its Durata and Optisure leads for use with MRI scans, St. Jude said, noting that it expects to update CE Mark labeling on many of its existing cardiac rhythm management devices in the coming months.
"St. Jude Medical is committed to providing MRI-compatible solutions for its ICD and pacemaker devices for patients and physicians worldwide. These products are already proven cardiac rhythm management technologies and now, due to extensive research and testing, they are available in the MRI environment. We will continue to develop advanced MRI-compatible technologies in order to ensure patient access to this important diagnostic tool," president Dr. Eric Fain said in a press release.
The Ellipse ICD is used to treat abnormally fast heart rhythms in patients. The device detects ventricular tachycardia or fibrillation and provides impulses to the heart to normalize the pace. If the impulses fail to balance heart rhythm, a more significant shock is sent to normalize heart rhythm.
"It’s not uncommon for patients with cardiac devices to have an unrelated medical need for an MRI scan over the lifetime of their device. The growing availability of MRI-compatible technologies offered by St. Jude Medical is significant for patients, because it now means they will have access to this important diagnostic tool without compromising their device performance," noted Dr. Amir Zaidi of the U.K.’s Manchester Royal Infirmary.
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