EMBLEM™ MRI S-ICD System

Subcutaneous Implantable Defibrillator

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EMBLEM S-ICD
EMBLEM S-ICD provides Protection Without Touching the Heart
EMBLEM S-ICD Protects Against Sudden Cardiac Arrest
EMBLEM MRI S-ICD System Animation
EMBLEM MRI Subcutaneous Implantable Defibrillator (S-ICD System)
EMBLEM S-ICD provides reliable defibrillation without touching the heart

The Only Device of its Kind

The S-ICD system was designed to address the main complications that may occur in Transvenous ICDs: Lead Complications and Infection.1
More than 18 years of clinical data shows that the S-ICD is safe and effective and has comparable performance to TV-ICD in treating VT/VF.2,3
The S-ICD System leaves the heart and vasculature UNTOUCHED, avoiding the complications associated with transvenous leads.

Product Details

The EMBLEM MRI S-ICD system provides effective defibrillation without transvenous leads, offering a less invasive solution for patients at risk of sudden cardiac arrest.

  • Eliminates potential for vascular injury. 
  • Preserves venous access. 
  • Reduces potential for systemic infection. 
  • Remains outside the sternum, never touching the heart. 

The innovation in S-ICD technology and implant technique has significantly improved over the last 18 years. The proven S-ICD system has been implanted in over 99,000+ patients Worldwide and has valuable clinical evidence of long-term efficacy, demonstrating consistently high spontaneous shock efficacy over an average of 5 years of follow-up – results that are not only comparable to, but better than results demonstrated in many TV-ICD studies.3-12 

 

S-ICD is Recommended in both US and EU Guidelines

Guidance 2017 AHA/ACC/HRS Guidelines13 2015 ESC Guidelines For S-ICD patients...
Class I   With high risk of infection, including Diabetic patients (up to 35% of the ICS population)14
Class IIa Without need of pacing (CRT, bradycardia, ATP)

The 2017 Guidelines by the American Heart Association (AHA), American College of Cardiology (ACC), and the Heart Rhythm Society (HRS) include recommended use of the S-ICD for ICD indicated patients with:

High Infection Risk

~75% of ICD Indicated Patients with ≥1 Comorbidities Associated with Device Infection.15,16,17

High infection risk chart
 

Inadequate Venous Access

 

Up to 61% of patients may have venous stenosis following initial device implantation.18

No Pacing Indication

% of VR and DR ICD Patients Under 75 with No Pacing Indication at Implant.

No pacing indication chart

 

TV-ICD Lead Complications in the Real World

The transvenous lead is the most common source of complications in a TV-ICD system. Data from over 40,000 patients from the OptumLabs Data Warehouse demonstrated that the incidence of mechanical and infectious complications of transvenous leads over long-term follow-up is much higher in the real world than in clinical studies. 

3-4% of patients with TV-ICD suffer lead malfunctions in the first year of implant21
About 25% mechanical failure rate for TV-ICD at 10 years21
4% infection rate for TV-ICD at 10 years21
freedom from complication
Kaplan-Meier plot of lead revision associated with a diagnosis of infection or mechanical complication for patients with an implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator. 

 
PRAETORIAN Results VuMedi

S-ICD as a First-Line Therapy
Results from the PRAETORIAN Trial


 
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