EMBLEM™ MRI S-ICD System

Subcutaneous Implantable Defibrillator

Patient eligibility

Learn about patient inclusion and exclusion criteria for the MODULAR ATP Clinical trial. Enrollment of the pivotal MODULAR ATP Trial is complete.

Key Resources

EMBLEM S-ICD Indications, Safety and Warnings

View MODULAR ATP Trial Results

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Trial inclusion criteria

What type of patient would benefit from Modular CRM (mCRM™)*?

1. Indicated for ICD

Patient must meet one of the following criteria:

Existing S-ICD patient
De novo patient with class I, IIa or IIb guideline ICD indications^{1, 2**}

*Caution: Investigational Device. Limited by US law to investigational use only. Not available for sale.

**Includes TV-ICD patients with system fully explanted during or prior to full coordinated system implant.

2. Risk for MVT

Patient must be at risk for Monomorphic Ventricular Tachycardia (MVT) based on at least one of the following:

Any LVEF

Sustained VT/VF (secondary prevention) with significant scar
Syncope deemed to be arrhythmic in origin

LVEF ≤ 50%

Sustained VT/VF (secondary prevention)
Non-sustained MVT

LVEF ≤35%

Ischemic cardiomyopathy
Non-ischemic cardiomyopathy with significant scar

Exclusion criteria

Patient with an ongoing complication due to Cardiac Implantable Electronic Device (CIED) infection or CIED explant
Transvenous lead remnants within the heart from a previously implanted CIED (Note: transvenous lead remnants outside the heart (e.g., in the SVC) are allowed)
Patient indicated for implantation of a dual chamber pacemaker or cardiac resynchronization therapy (CRT)
Patient with another implanted medical device that could interfere with implant of the leadless pacemaker, such as an implanted inferior vena cava filter or mechanical tricuspid heart valve
Patient with Acute Coronary Syndrome (i.e. Acute Myocardial Infarction, Unstable Angina) within 40 days

For full inclusion and exclusion criteria, please visit https://clinicaltrials.gov/.

MODULAR ATP trial

Learn about the MODULAR ATP clinical trial design, primary effectiveness and safety endpoints, timelines and more.

mCRM technology

Discover how a modular approach to ICD therapy may reduce the risks of TV leads while providing pacing if needed.

Pre-clinical data

See the pre-clinical data evaluating the use of Modular CRM (mCRM™) technology* in animal subjects.

*Caution: Investigational device. Limited by US law to investigational use only. Not available for sale.

References

1. Al-Khatib, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. (2018); 138:e272-e391.

2. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). European Heart Journal (2015) 36, 2793–2867.

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