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

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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 Infection^2-4

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 Implant^5-6

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

Chart showing the S-ICD cumulative event rate at five years was non-inferior to TV-ICD.

Chart showing S-ICD had lower inappropriate shocks (IAS) at one year than TV-ICD.

Charts showing S-ICD had fewer device- and lead-related complications than TV-ICD.

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 of S-ICD patient comorbidities across 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 Considered^1,8	TV-ICD Required^1,8	TV-ICD Considered^1,8
Evaluating Need for Brady Pacing^13-15	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 ATP^17,18	Ischemic or non-ischemic heart failure or ICD-indicated patient with NO history of recurrent sustained monomorphic VT	X
High or Low Risk for ATP^17,18	ICD-indicated patient WITH a history of recurrent sustained monomorphic VT amenable to ATP therapy		X