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08-10-2016, 08:49 PM
Boston Sci’s EMBLEM MRI Subcutaneous Implantable Defibrillator FDA Approved
http://www.medgadget.com/wp-content/uploads/2016/08/S-ICD.jpghttp://www.medgadget.com/wp-content/uploads/2016/08/EMBLEM-S-ICD.jpg
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.
Flashbacks:*Subcutaneous Implantable Cardiac Defibrillator FDA Approved… (http://www.medgadget.com/2012/10/subcutaneous-implantable-cardiac-defibrillator-fda-approved.html)
Product page: EMBLEM S-ICD… (http://www.bostonscientific.com/en-US/products/defibrillators/emblem-s-icd-system.html?cid=dsp59769)
Source: Boston Scientific… (http://news.bostonscientific.com/2016-08-09-Boston-Scientific-An**unces-U-S-FDA-Approval-Of-EMBLEM-MRI-S-ICD-System)
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http://www.medgadget.com/wp-content/uploads/2016/08/S-ICD.jpghttp://www.medgadget.com/wp-content/uploads/2016/08/EMBLEM-S-ICD.jpg
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.
Flashbacks:*Subcutaneous Implantable Cardiac Defibrillator FDA Approved… (http://www.medgadget.com/2012/10/subcutaneous-implantable-cardiac-defibrillator-fda-approved.html)
Product page: EMBLEM S-ICD… (http://www.bostonscientific.com/en-US/products/defibrillators/emblem-s-icd-system.html?cid=dsp59769)
Source: Boston Scientific… (http://news.bostonscientific.com/2016-08-09-Boston-Scientific-An**unces-U-S-FDA-Approval-Of-EMBLEM-MRI-S-ICD-System)
This post Boston Sci’s EMBLEM MRI Subcutaneous Implantable Defibrillator FDA Approved (http://www.medgadget.com/2016/08/boston-scis-emblem-mri-subcutaneous-implantable-defibrillator-fda-approved.html) appeared first on Medgadget (http://www.medgadget.com).
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