S-ICD System Overview


 

 

Evolving ICD Technologies

For years, implantable cardioverter defibrillators, or transvenous ICDs (TV-ICDs) have saved the lives of patients at risk of sudden cardiac arrest.

 

Today, a new exciting therapeutic solution for patients is available: the S-ICD™ System, which provides patients protection from sudden cardiac arrest without touching the heart.

 

  Listen to Dr. Michael Gold and Dr. Martin Burke discuss the S-ICD System »

 

S-ICD Rationale

 

Protection Without Touching the Heart

The S-ICD System is the world's first and only subcutaneous implantable defibrillator that provides protection from sudden cardiac arrest (SCA) while leaving the heart and vasculature untouched. Like transvenous ICDs, the S-ICD System utilizes a pulse generator capable of delivering life-saving therapy. Unlike transvenous ICDs, the S-ICD System uses a subcutaneous electrode and analyzes the heart rhythm – rather than individual beats – to effectively sense, discriminate, and convert VT/VF. For years patients' lives have been extended by implanting transvenous implantable defibrillators. Now the S-ICD System provides a new solution to protect patients from SCA, without touching the heart.

 

S-ICD torse image with text

 

Effective Defibrillation Without Transvenous Leads

  • Effective detection and conversion of induced and spontaneous VT/VF episodes1,2
  • Low rates of significant clinical complications1
  • Effective discrimination of AF and SVT from VT/VF1,2,3
  • Rate of inappropriate therapy is consistent with transvenous ICDs1,2,3

Sophisticated Technology

  • Identifies and classifies the heart rhythm, rather than individual beats
  • Revolutionary approach to sensing the subcutaneous signal
  • INSIGHT™ algorithm effectively discriminates between treatable and other high-rate supra-ventricular events
  • Designed to allow self-termination of non-sustained tachyarrhythmia

Durable Subcutaneous Electrode Design

  • 45cm length, which includes two sensing electrodes and one shocking coil
  • Subcutaneous placement avoids intra-cardiac biomechanical stresses
  • Multistrand cable-core design provides exceptional tensile strength
  • Durable polyurethane body is highly resistant to abrasion

New Solution for a Broad Range of Patients at Risk for SCA

  • Effective for a majority of primary and secondary ICD candidates*
  • Alternative for TV-ICD replacements due to lead malfunction/infection
  • Ideal for primary electrical or structural heart disease
  • Appropriate for a broad range of body types

 

 

 

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* Indication for Use
The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.



1. Burke M, et al. Safety and Efficacy of a Subcutaneous Implantable-Debrillator (S-ICD System US IDE Study). Late-Breaking Abstract Session. HRS 2012.
2. Lambiase PD, et al. International Experience with a Subcutaneous ICD; Preliminary Results of the EFFORTLESS S-ICD Registry. Cardiostim 2012.
3. Gold MR, et al. Head-to-head comparison of arrhythmia discrimination performance of subcutaneous and transvenous ICD arrhythmia detection algorithms: the START study. J Cardiovasc Electrophysiol. 2012;23;4:359-366.

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