FDA Approves Boston Scientific’s New Defibrillator

Boston Scientific, a NEC member, recently received approval from the U.S. Food and Drug Administration (FDA) for its new defibrillator system.

The EMBLEM™ MRI Subcutaneous Implantable Defibrillator (S-ICD) System is “the latest addition to the company’s growing line of ImageReady™ MR-conditional devices, which allow patients to undergo magnetic resonance imaging (MRI) safely.” The system is a proven treatment option for sudden cardiac arrest, which does not touch the heart or vasculature, reducing the risk associated with traditional systems.

Kenneth Stein, M.D. of Boston Scientific said, “Now with FDA approval, patients receiving the EMBLEM MRI S-ICD System, as well as patients who previously were implanted with an EMBLEM S-ICD System, have reassurance they can safely undergo MR scans while remaining protected from cardiac arrest.”

The New England Council congratulates Boston Scientific on receiving FDA approval for its defibrillator system.

Read more in the Boston Scientific press release.

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