Technology | Implantable Cardioverter Defibrillator (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

PREDICT-AF trial showed first time there is extensive extracellular matrix remodeling. #HRS2020 #Heartrhythm2020. Marilyn Fornell
News | Atrial Fibrillation | May 19, 2020
May 19, 2020 — Structural changes of the atrium may occur long before the onset of atrial fibrillation (AF), and the
Results of the Atrial Fibrosis Predicts Recurrent Stroke Or New Atrial Fibrillation In Patients With Embolic Stroke Of Undetermined Source - A Multi-Center Study at HRS 2020. #HRS2020 #Heartrhythm2020,
News | Atrial Fibrillation | May 19, 2020
May 19, 2020 — Atrial disease has been implicated in embolic stroke of undetermined source (ESUS) and a late-breaking
Contact Force Sensing Catheter Improved Outcomes in Persistent Atrial Fibrillation Ablation. #HRS2020 #heartrhythm2020
News | Atrial Fibrillation | May 13, 2020
May 13, 2020 — The PRECEPT study testing the use of the Biosense Webster Thermocool Smarttouch SF Catheter for the tr
The Swiss-AF study shows High Incidence Of Silent Brain Infarcts Found in Anticoagulated Atrial Fibrillation Patients. #Heartrhythm2020 #HRS20 #HRS2020
News | Atrial Fibrillation | May 08, 2020
May 8, 2020 – A new clinical study found that patients with...
PINNACLE FLX Study of New Watchman FLX LAA Occluder Meets Safety and Efficacy Endpoints. #Heartrhythm2020 #HRS20 #HRS2020
News | Atrial Fibrillation | May 08, 2020
May 8, 2020 — Positive 12-month results were announced today from the...
The first-in-human results show positive results for Medtronic's pulsed field ablation in safety and efficiency. #Heartrhythm2020 #HRS2020 #HRS20
News | Atrial Fibrillation | May 08, 2020
May 8, 2020 — New clinical trial reveals the first-in-human results for paroxysmal or persistent atrial fibrillation
POPULAR TAVR trial Shows Oral Anticoagulants Alone in atrial fibrillation  (AF) Patients Reduces Bleeding Post TAVR, transcatheter aortic valve replacement. #ACC20 #ACC2020
News | Atrial Fibrillation | March 29, 2020
March 29, 2020 — Patients with atrial fibrillation (AF) who took oral anticoagulants alone after undergoing transcath
Medtronic's PulseSelect Pulsed Field Ablation (PFA) System

Medtronic's PulseSelect Pulsed Field Ablation (PFA) System.

News | Atrial Fibrillation | January 31, 2020
January 31, 2020 – The U.S.
Frequent Drinking Greater Risk Factor for Heart Rhythm Disorder Than Binge Drinking

Image courtesy of the American Heart Association.

News | Atrial Fibrillation | October 22, 2019
October 22, 2019 —  Drinking small amounts of alcohol frequently is linked with a higher likelihood of...