EMBLEM™ S-ICD System

Subcutaneous Implantable Defibrillator

por-que-cdi-s

Implant Procedure

Advanced Technology

Patient Selection

Key Features and Specifications

Implanted in a Broad Range of Patients

The subcutaneous placement of the EMBLEM S-ICD System serves as an effective solution for a broad range of patients at risk for sudden cardiac arrest (SCA).

Key Resources

Important Safety Information Patient Information
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The S-ICD System is an effective option for a majority of ICD candidates, both with primary and secondary indications.

S-ICD System Patient Population from the IDE Study1

The S-ICD System is an effective option for a majority of ICD candidates,
both with primary and secondary indications.

13.4% of S-ICD System implants were replacements for transvenous ICDs, some due to system malfunctions and/or infections.

S-ICD System Implants from the Pooled Analysis2

13.7% of S-ICD System implants were replacements for transvenous ICDs, some due to system malfunctions and/or infections.

The S-ICD is suitable for both primary and secondary prevention patients. Furthermore, 43% of the Pooled Analysis population were Primary Prevention Patients with an EF ≤35%. Because there are no leads in the heart or vasculature it is an option for patients at who have had a transvenous ICD system removed due to infection or are at high risk for infection. The figure below displays data on patient demographics from the Pooled Analysis.
Patient Demographics

Who should be considered for the S-ICD System*

Characterization of Patient Groups for S-ICD Implantation based on the Poole and Gold editorial article:

S-ICD System is the
preferred device3

  • No venous access (occluded or congenital)
  • High risk of complications for TV-ICD (dialysis, pediatric immunocompromised)
  • Channelopathies (LQT, Brugada, HCM)
  • Previous device infections or lead failures
  • H/O endocarditis

S-ICD System should be
strongly considered3

  • Young patients
  • Life expectancy > 10 yr
  • Primary prevention with ischemic/non-ischemic heart failure
  • Prosthetic valves
  • Women (preferred generator placement)
  • Selected secondary prevention (survivors of out of hospital VF, no evidence of MVT)

S-ICD System should be
avoided3

  • Systolic HF and LBBB --> CRT
  • Symptomatic bradycardia requiring pacing
  • Recurrent sustained MVT for whom ATP is deemed appropriate

* Based on the article by Dr. Jeanne Poole and Dr. Michael Gold: Poole, J and Gold, M. Who Should Receive the Subcutaneous Implanted Defibrillator? The Subcutaneous Implantable Cardioverter Defibrillator Should be Considered in all ICD patients Who Do not Require Pacing. Circulation 2013; 6: 1236-1245.  

Sources:

  1. Weiss, et al. The safety and efficacy of a totally subcutaneous implantable defibrillator. Circulation 2013.
  2. 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.
  3. Poole, J and Gold, M. Who Should Receive the Subcutaneous Implanted Defibrillator? The Subcutaneous Implantable Cardioverter Defibrillator Should be Considered in all ICD patients Who Do not Require Pacing. Circulation 2013; 6: 1236-1245.

Referências

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