EMBLEM™ MRI S-ICD System

Subcutaneous Implantable Defibrillator

EMBLEM MRI builds upon the excellent clinical performance of the previous generations of S-ICD. EMBLEM MRI provides protection for patients at risk of sudden cardiac death (SCD), while avoiding complications associated with transvenous leads.

Key Resources

Product Spec Sheet S-ICD Patient Website EHRA S-ICD Webinar

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Product Advantages


Effective Defibrillation without Transvenous Leads

EMBLEM™ MRI S-ICD – 3rd Generation S-ICD

      

ImageReadyTM technology

  • Full Body, 1.5T
  • MRI-conditional System*38,39

   

Thinner EMBLEM S-ICD Device Thinner EMBLEM S-ICD Device

* When conditions of use are met

Advanced INSIGHTTM with SMART Pass technology

  • Effective in AF/SVT discrimination24 and furthur reduction in Inappropriate Shocks due to TWOS 38

Longevity Battery Technology Longevity Battery Technology

AF MonitorTM

  • Designed to assist in the detection of silent, new onset or the progrssion of AF38                                                    

Latitude Remote Patient Management Latitude Remote Patient Management

Evolving ICD Technologies

Implantable cardioverter-defibrillators (ICDs) save lives when used for the primary or secondary prevention of sudden cardiac death (SCD). Transvenous and epicardial systems are however associated with complications related to the difficulty of maintaining long-term lead integrity and vascular access.

EMBLEM less invasive diagram EMBLEM less invasive diagram

       

Transvenous Lead Survival Rate1

TV-ICD complications, both acute and chronic, are more prevalent than generally acknowledged1

Transvenous Lead Survival Rate Transvenous Lead Survival Rate

Complications associated with Transvenous Leads2

  • Endocarditis
  • Perforation
  • Hemothorax
  • Pneumothorax
  • Thromboembolic events
  • Vascular complications
  • Lead fractures
  • Lead extraction complications
  • Lead dislodgement

                           

S-ICD Electrode

The EMBLEM S-ICD Subcutaneous Electrode Designed for Durability

Less Biomechanical Stress

Located outside of the heart and ribcage, the EMBLEM S-ICD subcutaneous electrode is exposed to significantly less biomechanical stress than traditional transvenous leads:

  • Not exposed to the dynamics and force of cardiac motion (~100,000 flexes/day)
  • Not exposed to clavicular crush forces

Unique Construction

The subcutaneous electrode is uniquely designed to minimize the risk of insulation abrasion/breach and conductor fractures:

  • Multistrand cable-core design provides exceptional strength
  • Durable polyurethane insulator
  • No hollow core, no inner coils
  • Designed to withstand cardiopulmonary resuscitation (CPR) forces

         

Effective defibrillation…

 

…with performance equivalent to TV-ICD5

 

~ Adoption of dual-zone programming increased from 51% of patients registered during first enrollment quartile, to 95% of patient registered in the last enrollment quartile. This was associated with a 34% reduction of IAS incidence

…but without the risk6

S-ICD is designed to avoid transvenous lead issues

Pooled Data Analysis shows…5

  • Cardiac injuries
  • Systemic blood
    infections or endocarditis

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