EMBLEM™ MRI S-ICD System

The Subcutaneous Signal

The EMBLEM MRI S-ICD System uses a revolutionary approach to sensing, different from transvenous systems:
Far-field sensing allows the EMBLEM MRI S-ICD System to capture a high-resolution signal similar to a surface ECG.
Three sensing vectors provide different perspectives of a patient’s cardiac rhythm for optimal sensing. The EMBLEM MRI S-ICD System automatically identifies the best signal for rhythm detection.

Therapy Delivery

INSIGHTTM Technology

The EMBLEM MRI S-ICD System uses the highly sophisticated INSIGHT technology to identify and classify a heart rhythm – rather than individual beats – to effectively sense, discriminate, and convert VT/VF through a three phase process.

PHASE I - Detection

The DETECTION phase filters the subcutaneous (S ECG) signal and generates detections for further analysis.  A variety of profiles are used for detection of signals, including the new SMART Pass filter which is used to further reduce cardiac oversensing.

PHASE II - Certification

The CERTIFICATION phase analyses the detected events and classifies them as cardiac or noise. Four separate algorithms are used to prevent oversensing and ensure an accurate heart rate.

PHASE III - Therapy Decision

During the Therapy Decision phase, the INSIGHT algorithm discriminates between treatable and other high-rate events such as AF, sinus tachycardia, and other SVTs, helping to avoid inappropriate therapy. The Conditional and Shock Zone settings are programmable.

The Therapy Decision phase also incorporates features to confirm that therapy delivery is necessary. These include SMART Charge, Charge Confirmation and Shock Confirmation. The SMART Charge feature enhances the EMBLEM MRI S-ICD System‘s ability to prevent charging if non-sustained events are suspected and automatically extends initial detection time to allow for spontaneous termination.

INSIGHTTM with Smart Pass Technology

  • The SMART Pass feature activates an additional high-pass filter designed to reduce oversensing while still maintaining an appropriate sensing margin.1
  • SMART Pass is only applied in the sensing path, while the morphology is unchanged.1
  • In one study SMART Pass technology reduced T-wave oversensing (TWOS) by 82% compared to the Gen 1 S-ICD and 71% compared to the EMBLEM S-ICD2*.
*Based on simulated modelled EFFORTLESS patient episodes.
The SMART Pass filtering reduces the amplitude of lower frequency (slower moving) signals such as T-waves, by applying an additional High Pass filter (lets higher frequencies “pass“ through). Higher frequency (faster moving) signals such as R-waves, VT and VF remains largely unchanged.
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