S-ICD™ System

Subcutaneous Implantable Defibrillator

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.

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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.

Protection without touching the heart Protection without touching the heart

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

  • 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 SC

  • 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

Product Details

SQ-RX Pulse Generator Specifications

Mechanical Specifications

Model Number 1010
Size (H x W x D) 78.2 x 65.5 x 15.7 mm
Mass 145 g
Volume 69.9 cc
Longevity Normal use*: 5 years
Electrode compatibility Requires Q-TRAK subcutaneous electrode

Automatic Functions

Sensing configuration Primary (ring to can), Secondary (tip to can), Alternate (tip to ring)
Optimal sensing configuration automatically selected during Auto
Setup (manual programming optional)
Gain selection x1, x2
Optimal gain selection automatically selected during Auto Setup
(manual programming optional)
Rhythm discrimination INSIGHTᵀᴹ algorithm automatically activated when the Conditional Shock Zone is programmed
Shock polarity Standard (coil to can), reserve (can to coil)
Automatically selects and stores last successful shock polarity
Smart Chargeᵀᴹ Shock polarity alters automatically after failed shock
Electrode compability Automatically extends initial detection time to allow self termination of non-sustained tachyarrhythmias
Internal warning system Audible tone alerts patient to elective replacement indicator, electrode impedance out of range, prolonged charge times, failed device integrity check

Programmable Parameters

Shock Zone 170 bpm - 250 bpm (steps of 10 bpm)
Conditional Shock Zone Off, On 170 bpm - 240 bpm (minimum 10 bpm less than Shock Zone)
S-ICD System Therapy Off, On
Post-shock pacing Off, On (50 ppm, max 30 sec, demand-based)
Induction capability 1-10 sec (50 Hz/200 mA)
Delivered Energy 80J biphasic (only programmable during manual shock and induction test: 10J - 80J, steps of 5J)
Shocks per episode Maximum of 5 shocks

Diagnostics

Episode storage S-ECG storage for over 40 arrythmic events (treated & untreated)
Other data Electrode impedance
System status (remaining battery life, patient alerts, etc.)
Date and time stamp

Q-Trak® Subcutaneous Electrode Specification

Q-TRAK Q-TRAK

Specifications

Model Number 3400
Type Tripolar
Length 45 cm
Distal tip size (Diameter) 12 Fr / 4 mm
Coil size (Diameter) 9 Fr / 3 mm
Electrode shaft size (Diameter) 7 Fr / 2.33 mm
Sensing surface area

Distal
Proximal


46 mm
36 mm²
Sensing location
Distal
Proximal
Distal electrode tip
120 mm from tip
Defibrillation surface area 750 mm²
Defibrillation location 20 - 100 mm from tip
Materials  
Electrodes Polyurethane
Conductors MP35N
Connector Pin MP35N
Suture Sleeve Silicone

Ordering Information

1010 Pulse Generator
3400 Electrode
3200 Tablet Programmer
4760 Suture Sleeve
*3010 Electrode - Cameron Health model number*

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