EMBLEM™ MRI S-ICD System

Subcutaneous Implantable Defibrillator

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EMBLEM S-ICD provides Protection Without Touching the Heart
EMBLEM S-ICD Protects Against Sudden Cardiac Arrest
EMBLEM MRI S-ICD System Animation
EMBLEM MRI Subcutaneous Implantable Defibrillator (S-ICD System)
EMBLEM MRI S-ICD System Protects Against Sudden Cardiac Arrest

The Only Device of its Kind

The EMBLEM MRI S-ICD is the only subcutaneous implantable defibrillator that provides protection from both sudden cardiac death and the risks and complications associated with transvenous leads.

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Product Details

The EMBLEM MRI S-ICD system provides effective defibrillation without transvenous leads, offering a less invasive solution for patients at risk of sudden cardiac arrest.

  • Preserves the vasculature
  • Eliminates potential for vascular injury, transvenous lead insertion complications, lead-associated tricuspid regurgitation,  mechanically induced pro-arrhythmia, and transvenous lead failure and associated extraction risk
  • Remains outside the sternum, never touching the heart
EMBLEM MRI S-ICD Pulse Generator Mechanical Specifications
Model Number A219
Size (W x H x D) 83.1 x 69.1 x 12.7 mm
Mass 130 g
Volume 59.5 cc (cm³)
Projected Longevity 8.7 years*
Battery Chemistry Boston Scientific Li/MnO2
Warranty 6 years**
Remote Patient Monitoring Capability Enabled for use with LATITUDE™ NXT remote patient management
* Defined as 3 full-energy capacitor charges per year.  Based on LATITUDE Date on File, Boston Scientific 2017.
**For full warranty terms and conditions go to www.bostonscientific.com/en-US/pprc/warranty-info-forms.html
 

Clinical Information

The 2017 Guidelines by the American Heart Association (AHA), American College of Cardiology (ACC), and Heart Rhythm Society (HRS) include recommended use of the S-ICD for ICD indicated patients with1:

  

 

High Infection Risk

~75% of ICD Indicated Patients with ≥1 Comorbidities Associated with Device Infection.2, 3, 4

High infection risk chart
 

Inadequate Venous Access

 

Up to 61% of patients may have venous stenosis following initial device implantation.5

No Pacing Indication

% of VR and DR ICD Patients Under 75 with No Pacing Indication at Implant.

No pacing indication chart
 

Dr. Reinoud Knops Discusses the PRAETORIAN Trial at HRS in 2020
PRAETORIAN is the first prospective randomized head-to-head clinical trial confirming that the S-ICD can be the preferred therapy choice over the TV-ICD for protection from sudden cardiac arrest.
Clinical Information image
 

Ordering Information

Model Number Description
A219 EMBLEM MRI S-ICD Pulse Generator
3501 EMBLEM S-ICD Electrode
4711 EMBLEM S-ICD Electrode Insertion Tool
3200 EMBLEM S-ICD Programmer
 

Reimbursement

Rhythm Management Reimbursement Resources
 

Training & Education

Explore continuing education courses, best practices modules and other training and resources for S-ICD.

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why sicd

Why S-ICD?

See how S-ICD helps protect patients at risk for sudden cardiac death while also eliminating the risk of TV-ICD lead complications.

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Implant Procedure

Implant Procedure

Learn about advancements in the S-ICD implant procedure, including the 2-incision and intermuscular implant techniques.

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Clinical Data

Clinical Data

Explore clinical outcomes and learn about the first prospective, randomized, non-inferiority clinical trial comparing S-ICD to TV-ICD.

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References

1. Al-Khatib, SM, Stevenson, WG, Ackerman, MJ, et al., 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. Heart Rhythm, 2017.

2. Polyzos, KA, Konstantelias, AA, and Falagas, ME, Risk factors for cardiac implantable electronic device infection: a systematic review and meta-analysis. Europace, 2015. 17(5): p. 767-777. 

3. Greenspon, AJ, Patel, JD, Lau, E, et al., 16-Year Trends in the Infection Burden for Pacemakers and Implantable Cardioverter-Defibrillators in the United States. Journal of the American College of Cardiology, 2011. 58(10): p. 1001-1006. 

4. Friedman, DJ, Parzynski, CS, Varosy, PD, et al., Trends and In-Hospital Outcomes Associated With Adoption of the Subcutaneous Implantable Cardioverter Defibrillator in the United States. JAMA Cardiol, 2016. 1(8): p. 900-911.

5. Kusumoto, FM, Schoenfeld, MH, Wilkoff, BL, et al., 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm, 2017.

6 Gasparini, M, Lunati, MG, Proclemer, A, et al., Long Detection Programming in Single-Chamber Defibrillators Reduces Unnecessary Therapies and Mortality. JACC: Clinical Electrophysiology, 2017.

7. LATITUDE Data on File,  Boston Scientific 2017.

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