EMBLEM™ MRI S-ICD System

Subcutaneous Implantable Defibrillator

Which Patients Should Be Considered for an S-ICD?

The S-ICD is guideline recommended for patients at high risk of infection, inadequate venous access and any patient without a pacing indication – the majority of ICD-indicated patients.1
Logo showing that S-ICD is guideline recommended by ESC, AHA, ACC and HRS.

S-ICD is Guideline Recommended

Data visualization showing 75% of ICD-indicated patients have ≥1 comorbidity associated with device infection.
75% of ICD-Indicated Patients
Have ≥1 Comorbidity Associated
with Device Infection2-4
Data visualization showing 70% of DR and VR ICD patients under 75 have no pacing indication at implant.
70% of DR & VR ICD Patients
Under 75 Have No Pacing
Indication at Implant5-6
Data visualization showing 61% of patients may have venous stenosis following initial device implantation
61% of Patients May Have
Venous Stenosis Following
Initial Device Implantation7

Clinical Data Supports S-ICD for a Broad Group of Patients

Both the PRAETORIAN and UNTOUCHED studies confirm S-ICD should be considered the first choice for all ICD-indicated patients without a pacing indication.

PRAETORIAN8

This investigator-sponsored trial demonstrated S-ICD had comparable performance to TV-ICD, despite including primarily older S-ICD devices and implant techniques. According to the PRAETORIAN study, S-ICD:

  • Had significantly fewer lead-related complications (1.4% vs. 6.6%, P=0.001)
  • Demonstrated fewer serious infections requiring extraction (8 TV-ICD vs. 4 S-ICD)
  • Showed a trend in fewer overall complications (5.9% vs. 9.8%, P=0.11); likely to be significantly lower at 8 years in PRAETORIAN XL

 

UNTOUCHED9

The UNTOUCHED study demonstrated patients with EMBLEM MRI S-ICD with SMART Pass had a 2.4% rate of inappropriate shocks at 1 year, which is as low or lower than TV-ICD devices.5,8,10-11

As S-ICD Technology Evolves, So Does the Clinical Data

Over 82,000+ S-ICD patients and counting have received protection from both sudden cardiac death and the risks and complications associated with transvenous leads. Early S-ICD trials typically had younger patients with less advanced heart disease and “niche” indications, including channelopathies, hypertrophic cardiomyopathy, congenital heart disease or previous ICD indication. However, both the PRAETORIAN and UNTOUCHED studies included older and sicker patients. In fact, UNTOUCHED included the most traditional cohort of patients (primary prevention, LVEF ≤ 35%) and showed the S-ICD has lower inappropriate shock (IAS) rates than TV-ICDs.

 

Bar charts showing S-ICD patient comorbidities across a variety of studies, including IDE, EFFORTLESS, PAS, PRAETORIAN and UNTOUCHED.

Patient Comorbidities and S-ICD

It’s important to consider patient comorbidities and other risk factors for complications when determining whether a TV-ICD is required or if a patient should be offered both S-ICD and TV-ICD when taking a shared decision-making approach to the treatment decision.

 

 

Patient Comorbidities

S-ICD
Considered1,8

TV-ICD Required1,8

TV-ICD Considered1,8

Evaluating Need for Brady Pacing13-15

Brady pacing indication at implant

 

X

 

No current pacing indication, but has 1 or more of the following:

  • H/O CABG surgery
  • H/O atrial fibrillation
  • Age > 80
  • PR interval > 200 ms
 

 

X

No pacing indication at implant and age < 80

X

 

 

High Risk for TV Lead Failure16

Life expectancy > 8 years

X

 

 

High Risk for Infection2 H/O device infection

X

 

 

Prosthetic heart valve

X

 

 
On dialysis or renal insufficiency

X

 

 
Diabetes

X

 

 

Other risk factors:

  • COPD
  • Corticosteroid use
  • Oral anticoagulation
  • Class II-IV heart failure
  • Chronic skin disorder
  • Malignancy

X

 

 
High or Low Risk for ATP17,18

Ischemic or non-ischemic heart failure or ICD-indicated patient with NO history of recurrent sustained monomorphic VT

X

   

ICD-indicated patient WITH a history of recurrent sustained monomorphic VT amenable to ATP therapy

 

X

 

 

Physician Perspectives

Watch the videos below to hear what two leading physicians have to say about patient selection and S-ICD.
Automated Selection Tool
Patient Age and S-ICD

Training & Education


Explore continuing education courses, best practices modules and other training and resources for S-ICD.

Visit EDUCARE


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Why S-ICD?

See how S-ICD helps protect patients at risk for sudden cardiac death while also eliminating the risk of TV-ICD lead complications.

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Patient Screening

Discover the new changes made to the S-ICD Automated Screening Tool that increase efficiency and usability in S-ICD patient screening.

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Clinical Data

Explore clinical outcomes and learn about the first prospective, randomized clinical trial comparing S-ICD to TV-ICD.

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