Boston Scientific won FDA approval for its*EMBLEM MRI Subcutaneous Implantable Defibrillator (S-ICD), as well as retroactive*magnetic resonance (MR) conditional labeling for already implanted*EMBLEM S-ICDs. The new regulatory decision will allow patients sporting these devices to continue to be protected from cardiac arrest even while inside an MRI machine.
The new system includes*SMART Pass tech**logy, which can also be added to existing devices via a software update, that improves the accuracy of shock delivery so it’s only done when necessary. Additionally, the new*AF Monitor feature detects atrial fibrillation events and reports those to the patient’s cardiologist for closer inspection.
08-10-2016, 08:49 PM
Boston Sci’s EMBLEM MRI Subcutaneous Implantable Defibrillator FDA Approved
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