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Boston Scientific awarded US FDA approval for EMBLEM MRI S-ICD System for safe MR scans while remaining protected from cardiac arrest.

M2 EQUITYBITES-August 10, 2016-Boston Scientific awarded US FDA approval for EMBLEM MRI S-ICD System for safe MR scans while remaining protected from cardiac arrest

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Medical solutions company Boston Scientific (NYSE:BSX) revealed on Tuesday that it has received US Food and Drug Administration (FDA) approval for the EMBLEM MRI Subcutaneous Implantable Defibrillator (S-ICD) System, as well as magnetic resonance (MR) conditional labeling for all previously implanted EMBLEM S-ICD Systems.

The company said the new EMBLEM MRI S-ICD System is the latest addition to its growing line of ImageReady MR-conditional devices, which allow patients to undergo magnetic resonance imaging (MRI) safely.

In addition, the company's new EMBLEM S-ICD System is a proven treatment option for patients at risk of sudden cardiac arrest, that leaves the heart and vasculature untouched, thus reducing the risk of complications associated with conventional transvenous implantable cardioverter-defibrillator leads.

Earlier this year, the company received the CE Mark for the EMBLEM MRI S-ICD System and began commercialisation the product in Europe in June. In addition to MR-conditional labeling, the device introduces two new features to the market: the SMART Pass technology and Atrial Fibrillation (AF) Monitor.

According to the company, SMART Pass technology increases the accuracy of the INSIGHT Algorithm to help ensure patients receive appropriate therapy from the device only when necessary. The AF Monitor feature is a detection tool designed to alert physicians after the identification of AF so they can make more informed treatment decisions for their patients.

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Date:Aug 10, 2016
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