Clinical Overview

S-ICD Clinical Data

 Several landmark trials can confirm: S-ICD offers effective defibrillation while significantly reducing the risk of complications associated with transvenous leads.

Clinical Evolution of S-ICD

99,000+ patients implanted with S-ICDs worldwide - and counting

S-ICD History Timeline



Safety and Efficacy of the S-ICD System 

Spontaneous Conversion
Over a decade of clinical data have consistently demonstrated high spontaneous conversion rates for the S-ICD. Most recently, EFFORTLESS data demonstrated overall final shock efficacy of 98% over long term follow up of 5 years.1 The S-ICD has comparable success rates in treating VT/VF when compared to studies with TV-ICD and even higher success rates in some instances.

Safety and Efficacy of the S-ICD System

The spontaneous conversion rates for S-ICD are comparable to TV-ICD – and are even better in certain studies.1-8
Safety and Efficacy of the S-ICD System
Mortality
In the PRAETORIAN trial (N=849) the mortality rate was low for both S-ICD and TV-ICD over 4 years. The number of sudden cardiac deaths was identical for S-ICD and TV-ICD despite enrolling a sicker patient population than in previous S-ICD studies.9



Avoiding Complications with the S-ICD System 

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 Warehouse12 demonstrated that the incidence 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 implant10
About 25% mechanical failure rate for TV-ICD at 10 years10
4% infection rate for TV-ICD at 10 years10

Complications - The PRAETORIAN Trial

Head-to-head landmark PRAETORIAN trial demonstrated fewer device and lead related complications when comparing S-ICD to TV-ICD over a 4 year follow-up period in more typical ICD patients.9
Fewer Lead Related Complications
Fewer Lead Related Complications
Fewer Device Related Complications
Fewer Device Related Complications

 

Low need for Brady/ATP 

Only 20 of 4,159 patients (0.4%) across four major S-ICD studies required a TV-ICD for ATP (10 pts. 0.2%) or pacing (10 pts., 0,2%).

Low need for Brady/ATP 



Decreasing IAS Rates in More Typical ICD Patient Population 

The IAS Rate of 2.4% at 1 Year for EMBLEM MRI S-ICD in UNTOUCHED is Lower than IAS Rates in TV-ICD Studies.

Decreasing IAS rates in more typical ICD patient population
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