EMBLEM™ MRI S-ICD System
Subcutaneous Implantable Defibrillator
The Pooled Analysis, published in the Journal of the American College of Cardiology, supports the long term safety and efficacy of the S-ICD System in a broad range of patients. 43% of the patients in this analysis were primary prevention patients with reduced ejection fraction who were at high risk of sudden cardiac death. The analysis followed 882 patients enrolled for an average of nearly 2 years.1
1) No systemic infections, endocardities, cardiac injuries and electrode failures in this analysis.1
3) 98.2% spontaneous shock efficacy was similar to results found in TV-ICD studies in treating spontaneous arrhythmias.
2-Year Pooled Analysis Results
- Burke MC et al. Pooled Analysis of the EFFORTLESS and IDE Registry. JACC 2015; online April 20th. This analysis included only S-ICD System Model 1010.
- NCDR Analysis (Peterson et al, JAMA 2013)
- Meta-analysis (van Rees et. al. JACC 2011)
- Gold MR et al. Circulation 2002;105:2043-2048.