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.
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
| 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 |
| 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 |
| 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 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
| 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* |