Boston Scientific receives CE Mark for MRI labelling of Emblem systems

Boston Scientific has been granted European CE Mark approval for its Emblem subcutaneous implantable defibrillator (S-ICD) systems to be used in conjunction with magnetic resonance imaging (MRI) technology.

Its new Emblem MRI S-ICD system has been approved for use in these situations, with MR conditional labelling also applied to all of its previously implanted EMBLEM S-ICD Systems.

The devices are intended for patients at risk of sudden cardiac arrest. Thanks to this new approval, patients who have been implanted with these systems will be able to undergo full-body MR scans in 1.5 Tesla environments when the conditions of use are met.

Dr Kenneth Stein, chief medical officer for rhythm management at Boston Scientific, said: "The Emblem S-ICD System is a compelling treatment option for the majority of ICD-indicated patients that provides protection from cardiac arrest without invading the heart and blood vessels."

Key features of the system include its use of Smart Pass technology, meaning patients receive therapy from the device only when a necessary heart rhythm for effective arrhythmia treatment has been identified.

Its Atrial Fibrillation (AF) Monitor feature, meanwhile, alerts physicians after the identification of AF to help them make more informed treatment decisions.