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FDA approves MRI-compatible subcutaneous ICD
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Boston Scientific announced that the FDA approved a subcutaneous implantable cardioverter defibrillator designed for compatibility with MRI, as well as granted MR-conditional labeling to previous versions of its subcutaneous implantable cardioverter defibrillator.
The decisions mean patients implanted with the devices can safely undergo MR scans, according to a press release from the company.
The device designed for compatibility with MRI (Emblem MRI S-ICD System, Boston Scientific) received a CE mark for use in Europe earlier in 2016, includes a new version of an algorithm (Smart Pass) to ensure patients receive appropriate therapy only when needed, and contains a feature (Atrial Fibrillation Monitor) to alert physicians when the device identifies AF, the company stated in the release.
The company stated that the FDA previously granted approval to its MR-conditional pacemakers and, based on results of the ENABLE MRI study, is considering an MR-conditional indication for the firm’s conventional ICDs and cardiac resynchronization therapy devices.