EMBLEM™ MRI S-ICD System

Subcutaneous Implantable Defibrillator

EMBLEM MRI S-ICD INSIGHT™ 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.

Key Resources

Directions for Use Patient Information Indications, Safety and Warnings

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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 DELIVERY¹

INSIGHT Technology

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 EMBLEM MRI S-ICD utilizes the three discriminators described here in the conditional zone:

• Static Morphology Analysis

Identifies non shockable rhythms, utilizing the Normal Sinus Rhythm (NSR) template

• Dynamic Morphology Analysis

Identifies shockable polymorphic rhythms by comparing each complex to the previous ones

• QRS Width Analysis

Compares the QRS width to the NSR QRS width

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.