S-ICD™ System

Subcutaneous Implantable Defibrillator

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.

Key Resources

Indications, Safety, and Warnings

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Product Details

SQ-RX Pulse Generator Mechanical Specifications
Model Number 1010
Size (H x W X D) 78.2 x 65.578.2 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

* Defined as 3 full-energy capacitor charges per year.

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 INSIGHT™ algorithm automatically activated when the Conditional Shock Zone is programmed
Shock polarity Standard (coil to can), reverse (can to coil)
Adaptive Shock Polarity Shock polarity alters automatically after failed shock
Automatically selects and stores last successful shock polarity
Smart Charge™ 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 arrhythmic events (treated & untreated)
Other data Electrode impedance
System status (remaining battery life, patient alerts, etc.)
Date and time stamp

Q-Trak™ Subcutaneous Electrode Specification

Specifications

Model Number 3400/3010
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 mm2
  • 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
  • Insulation
  • Electrodes
  • Conductors
  • Connector pin
  • Suture Sleeve
 
  • Polyurethane
  • MP35N
  • MP35N
  • MP35N
  • Silicone

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Ordering Information

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

Clinical Information

Two important clinical studies have been instrumental in demonstrating the S-ICD System as a compelling solution for the treatment of sudden cardiac arrest in a broad range of patients.

The US Investigational Device Exemption (IDE) study was completed in 2011 and was the cornerstone for US FDA approval. The objective of this study was to evaluate the safety and effectiveness in the treatment of life-threatening ventricular arrhythmias. This study was published in 2013 in Circulation.

Learn more from Dr. Martin Burke below on the published data.  

The EFFORTLESS Registry is an ongoing registry in Europe and New Zealand aimed at demonstrating the early, mid-term, and long-term clinical outcome and cost effectiveness of the S-ICD System. An interim analysis was published in the European Heart Journal in early 2014.

Read the Manuscript Here

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