Technology | Implantable Cardioverter Defibrillators (ICD) | August 09, 2016

FDA Clears MRI-safe Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System

Approval grants MR-conditional labeling to all Emblem S-ICD systems, expands Boston Scientific’s ScienticImageReady portfolio

S-ICD, subcutaneous implantable cardioverter defibrillator, MRI safe ICD, Emblem
FDA Clears MRI-safe Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System

August 9, 2016 — The U.S. Food and Drug Administration (FDA) granted market 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 new Emblem MRI S-ICD System is the latest addition to the Boston Scientific's growing line of ImageReady MR-conditional electrophysiology devices, which allow patients to undergo magnetic resonance imaging (MRI) safely.

The 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 ICD leads.

 

Watch the video, "How to Install a Subcutaneous ICD System." 
 

In addition to MR-conditional labeling, the device introduces two new features to the market – SMART Pass technology and Atrial Fibrillation (AF) 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 resynchronization therapy systems via the global ENABLE MRI study.

Boston Scientific received CE mark for the Emblem MRI S-ICD system earlier this year and began commercialization in Europe in June.

For more information: www.bostonscientific.com/sicd

Related Content

Siemens Healthineers, Compressed Sensing technology, MRI, FDA approval, RSNA 2017
Technology | Magnetic Resonance Imaging (MRI)| February 21, 2017
Siemens Healthineers announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Compressed...
News | Cardiac Diagnostics| February 17, 2017
Levels of a protein in the blood associated with heart disease are also linked to early-stage brain damage, according...
Siemens Healthineers, Magnetom Sempra MRI system, FDA approval, RSNA 2017
Technology | Magnetic Resonance Imaging (MRI)| February 17, 2017
Siemens Healthineers announced that the U.S. Food and Drug Administration (FDA) has cleared the Magnetom Sempra 60-cm 1...
Medtronic, expanded indication, Freezor Xtra Cryoablation Catheter, AVNRT, atrioventricular nodal re-entrant tachycardia
Technology | Ablation Systems| February 16, 2017
Medtronic plc announced the U.S. Food and Drug Administration (FDA) has approved its Freezor Xtra Cryoablation Catheter...
Biotronik, ProMRI Configurator tool, MR-conditional cardiac devices, ProMRI SystemCheck
Technology | Implantable Cardiac Monitor (ICM)| February 14, 2017
Biotronik has developed an online tool that streamlines the workflow for physicians selecting the right magnetic...
News | Hypertension| February 13, 2017
Vascular Dynamics Inc. (VDI) announced that the U.S. Food and Drug Administration (FDA) has approved the company’s...
Sir Peter Mansfield, early MRI trials, obituary, University of Nottingham

Sir Peter Mansfield during the original MRI trials. Image courtesy of the University of Nottingham.

Feature | Magnetic Resonance Imaging (MRI)| February 09, 2017 | Jeff Zagoudis
February 9, 2017 — Sir Peter Mansfield, FRS, whose research aided the development of...
Xarelto, rivaroxaban, COMPASS study, ends early,
News | Antiplatelet and Anticoagulation Therapies| February 09, 2017
February 9, 2017 — Janssen Research & Development LLC (Janssen) announced that the Phase 3 COMPASS trial is stopp
GE Healthcare, Freelium technology, MRI magnet cooling, RSNA 2016, RSNA 2017
News | Magnetic Resonance Imaging (MRI)| February 06, 2017
At the 2016 Radiological Society of North America (RSNA) annual meeting, GE Healthcare unveiled Freelium, a magnet...
Technology | Advanced Visualization| February 06, 2017
February 6, 2017 — At the Society of Cardiac Magnetic Resonance (SCMR) 20th Annual Scientific Sessions, GE Healthcare
Overlay Init