EMBLEM™ MRI S-ICD System

Subcutaneous Implantable Defibrillator

S-ICD™ System 2-Year Results - Pooled Analysis of the IDE Study and EFFORTLESS Registry

43% of the S-ICD study population were primary prevention patients with an EF < or = to 35%
The Pooled Analysis combines the IDE Study and the EFFORTLESS Registry to evaluate complications and clinical outcomes. This analysis demonstrates worldwide experience for the safety and efficacy of the S-ICD System over a longer follow-up period and in a larger diverse population by pooling the databases.1
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

 
Largest patient cohort - Longest followup period - Most data


2-Year Pooled Analysis Results

S-ICD leaves the heart and vasculature untouched
1) No systemic infections, endocardities, cardiac injuries and electrode failures in this analysis.1
S-ICD had lower acute major complications than seen in the TV-ICD studies
2) Lower acute major complication rate (Hematoma, lead or device mal-position or displacement, pneumothorax) when compared to studies with TV-ICD, likely because S-ICD doesn't require vascular access.1

 
S-ICD effectiveness data showed similar results to TV-ICD data in treating spontaneous arrhythmias
3) 98.2% spontaneous shock efficacy was similar to results found in TV-ICD studies in treating spontaneous arrhythmias.
34% reduction with a 4.5% incidence of IAS at 6 months
4) Appropriate patient identification, operator experience and adoption of Dual Zone Programming demonstrated a trend of 34% reduction in Inappropriate Shock over time to a 4.5% incidence rate at 6 months.1

 
Complication rate decrease with increased S-ICD experience
5) Advances in operator experience associated with patient identification, prep and implant technique have further reduced infections and implant complications for S-ICD System.1

Sources:

  1. 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.
  2. NCDR Analysis (Peterson et al, JAMA 2013)
  3. Meta-analysis (van Rees et. al. JACC 2011)
  4. Gold MR et al. Circulation 2002;105:2043-2048.

 


Referências

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