EMBLEM™ MRI S-ICD System

Subcutaneous Implantable Defibrillator

Third Generation Technology

AF Monitor™
Designed to assist in the detection of silent, new onset, or the progression of atrial fibrillation.1 LATITUDE alerts help physicians to monitor and appropriately manage patient's condition.
SMART Pass
SMART Pass is a high pass filter designed to reduce cardiac over-sensing. It has been shown to reduce inappropriate therapy due to cardiac over-sensing by 71% from the EMBLEM device.3

Specifications and Reimbursement

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

7.3 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

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

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.

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

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

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 Specification

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

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