EMBLEM™ MRI S-ICD System

Subcutaneous Implantable Defibrillator

Key Features and Specifications

Explore product specifications and reimbursement information for EMBLEM MRI S-ICD. Plus, find out how S-ICD technology has evolved and improved over time.

The Evolution of S-ICD Technology

Timeline showing the evolution of S-ICD technology from 2009 to the present.

Next-Generation Technology: Key Features and Benefits

The EMBLEM MRI S-ICD is the second device in the EMBLEM S-ICD family and builds on previous enhancements in size, longevity and remote patient management. Like transvenous ICDs (TV-ICDs), the EMBLEM MRI S-ICD System uses a pulse generator capable of delivering life-saving therapy. Unlike TV-ICDs, the EMBLEM MRI S-ICD System leaves the heart and vasculature untouched, avoiding the risks and complications associated with transvenous leads.

Device Longevity

Real-world LATITUDE data projects average implanted EMBLEM S-ICD longevity of 8.7 years.1

SMART Pass

The SMART Pass filter is designed to reduce cardiac over-sensing and data has demonstrated that the inappropriate shock rate for S-ICD is now lower than TV-ICDs. Learn More About The UNTOUCHED Study.

AF Monitor

Designed to assist in the detection of silent, new onset or the progression of atrial fibrillation.2 AF Monitor will notify a clinician when at least six minutes of atrial fibrillation have been detected within a day.

LATITUDE™ NXT Remote Patient Management System

Remote patient management has been shown to decrease mortality, hospitalizations and in-clinic evaluations.3 The EMBLEM MRI S-ICD System leverages LATITUDE NXT remote monitoring technology to help improve patient outcomes and enhance clinic efficiencies.

EMBLEM MRI S-ICD Pulse Generator

Mechanical Specifications
Model Number A219
Size (W x H x D)

83.1 x 69.1 x 12.7 mm

Mass

130 g

Volume

59.5 cc (cm³)

Projected Longevity

8.7 years*

Battery Chemistry

Boston Scientific Li/MnO2

Warranty

6 years**

Remote Patient
Monitoring Capability

Enabled for LATITUDE™ NXT Remote Patient Management 

Reimbursement Information

S-ICD electrode C-Code:C1896

S-ICD pulse generator C-Code: C1722
 

*Based on 3 annual full energy charges
**For full warranty terms and conditions go to www.bostonscientific.com/en-US/pprc/warranty-info-forms.html
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)

Automatically selects and stores last successful shock polarity

Adaptive Shock Polarity

Shock polarity alters automatically after failed shock

SMART Charge

Automatically extends initial detection time to allow self termination of non-sustained tachyarrhythmias

SMART Pass High-pass filter designed to reduce oversensing while maintaining an appropriate sensing margin

Internal Warning System

Audible tone alerts patient to elective replacement indicator, electrode impedance out of range, prolonged charge times, failed device integrity check. NOTE: Exposure to MRI scanning can cause a permanent loss of the Beeper volume. The physician and patient should weigh the benefit of the MR procedure against the risk of losing the Beeper.

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)

AF Monitor Off, On (model A219 only)
MRI Protection Time-out (hours): 6, 9, 12, 24
Diagnostics  

Episode Storage

S-ECG storage for over 40 arrhythmic events (treated & untreated)

AF Episodes 7 stored (model A219 only)

Other Data

Electrode impedance
System status (remaining battery life, patient alerts, etc.)
Date and time stamp

EMBLEM™ S-ICD Electrode Model 3501

EMBLEM S-ICD Electrode Specification
Electrode Specifications  
Model Number
3501
Type Tripolar
Length 45 cm
Distal Type Size (Diameter) 11.5 Fr / 3.84 mm
Coil Size (Diameter) 9 Fr / 3 mm
Electrode Shaft Size (Diameter) 7 Fr / 2.33 mm
Sensing Surface Area
  
Distal: 36 mm2
Proximal: 46 mm2
Sensing Location Distal: At tip
Proximal: 120 mm from tip
Defibrillation Surface Area 750 mm2
Defibrillation Location
20 - 100 mm from tip
Materials Insulation: Polycarbonate, Polyurethane
Electrodes: MP35N
Conductors: MP35N
Connector Pin: MP35N
Integrated Suture Sleeve: Radiopaque White Silicone
Slit Suture Sleeve: Silicone
Electrode C-Code C1896

Training & Education

Explore continuing education courses, best practices modules and other training and resources for S-ICD.

Visit EDUCARE


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Why S-ICD?

See how S-ICD helps protect patients at risk for sudden cardiac death while also eliminating the risk of TV-ICD lead complications.

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Patient Selection

Learn why all ICD-indicated patients without a pacing need should be screened and strongly considered for S-ICD.

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Clinical Data

Explore clinical outcomes and learn about the first prospective, randomized clinical trial comparing
S-ICD to TV-ICD.

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