EMBLEM™ MRI S-ICD System
Subcutaneous Implantable Defibrillator
Inclusion Criteria
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.
![Intermuscular technique image 1](https://www.bostonscientific.com/en-EU/products/defibrillators/emblem-s-icd-system/modular-crm-system/modular-atp-patient-study-eligibility/_jcr_content/maincontent-par/image_copy_91549425.img.patient_selection_inclusion_criteria_desktop.jpg)
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 Study](/content/dam/bostonscientific/Rhythm%20Management/portfolio-group/EMBLEM_S-ICD/12_modular_atp/what-is-mcrm-therapy/modular_atp_icon_desktop.png)
MODULAR ATP Study
Learn about the MODULAR ATP Clinical Study design, primary effectiveness and safety endpoints, timelines and more.
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