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St. Jude Gets CE Mark For MRI-Safe Quadra CRT Pacemaker

St. Jude Medical says it has received CE Marking approval for magnetic resonance imaging (MRI) conditional labeling for its Quadra Allure MP cardiac resynchronization therapy pacemaker (CRT-P). The designation means patients in Europe implanted with the device can safely undergo full-body MRI scans of up to 1.5 Tesla to diagnose or monitor other conditions.

Approximately one-third of the total population of patients receiving CRT use devices that do not respond well to traditional bi-ventricular pacing therapy, according to St. Jude. The company says the Quadra's proprietary, first-to-market MultiPoint Pacing technology is designed to better manage these patients. Heart failure patients also are likely to experience heart failure progression, or have other serious medical conditions which warrant subsequent MRI scans post-implantation of cardiac devices.

                                                                                                                                                          -14/11/2016

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