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US FDA Approves Boston Scientific's Emblem MRI S-ICD System.

M2 PHARMA-August 10, 2016-US FDA Approves Boston Scientific's Emblem MRI S-ICD System


- US-based medical device maker Boston Scientific (NYSE: BSX) has received US Food and Drug Administration approval for the Emblem MRI Subcutaneous Implantable Defibrillator (S-ICD) System, as well as magnetic resonance 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 the company's growing line of ImageReady MR-conditional devices, which the company said allow patients to undergo magnetic resonance imaging safely.

Boston Scientific's Emblem S-ICD System is a 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.

The company received CE Mark for the Emblem MRI S-ICD System earlier this year and began commercialisation in Europein June.

In addition to MR-conditional labeling, the device introduces two new features to the market SMART Pass technology and Atrial Fibrillation Monitor.

The SMART Pass technology, also being added to previously implanted Emblem S-ICD Systems through a software update, 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.

Earlier this year, the company received FDA approval for the ImageReady MR-Conditional Pacing System, which includes ACCOLADE MRI and ESSENTIO MRI pacemakers as well as INGEVITY MRI pacing leads, designed to treat bradycardia.

Patients implanted with the full system are able to receive full-body MR scans in a 1.5 Tesla environment when conditions of use are met.

Additionally, the company is actively pursuing MRI compatibility for their currently approved implanted cardiac defibrillation and cardiac resynchronisation therapy systems via the global ENABLE MRI study.

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Publication:M2 Pharma
Date:Aug 10, 2016
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