EMBLEM™ MRI S-ICD System
Subcutaneous Implantable Defibrillator
Patient Study Eligibility
What Type of Patient Would Benefit from 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 indications1, 2*
*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:
- 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
- Ischemic cardiomyopathy
- Non-ischemic cardiomyopathy with significant scar
- 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/.
Study Site Locator
MODULAR ATP Study
Learn about the MODULAR ATP Clinical Study design, primary effectiveness and safety endpoints, timelines and more.
Discover how a modular approach to ICD therapy may reduce the risks of TV leads while providing pacing if needed.
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.