EMBLEM™ MRI S-ICD System
Subcutaneous Implantable Defibrillator
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.
Key Resources
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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 |
**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
Inadequate Venous Access
No Pacing Indication
% of VR and DR ICD Patients Under 75 with No Pacing Indication at Implant.
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
Training & Education
Explore continuing education courses, best practices modules and other training and resources for S-ICD.
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.
Implant Procedure
Learn about advancements in the S-ICD implant procedure, including the 2-incision and intermuscular implant techniques.
Clinical Data
Explore clinical outcomes and learn about the first prospective, randomized, non-inferiority clinical trial comparing S-ICD to TV-ICD.
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. Data on VR devices from LATITUDE Boston Scientific data on file.