|SQ-RX Pulse Generator Mechanical Specifications|
|Size (H x W X D)||78.2 x 65.578.2 x 65.5 x 15.7 mm|
|Longevity||Normal use*: 5 years|
|Electrode Compatibility||Requires Q-TRAK subcutaneous electrode|
* Defined as 3 full-energy capacitor charges per year.
|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|
|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|
|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
|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
|Defibrillation surface area||750 mm2|
|Defibrillation location||20 - 100 mm from tip|
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.