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
Safety and Efficacy of the S-ICD System
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.
The spontaneous conversion rates for S-ICD are comparable to TV-ICD – and are even better in certain studies.1-8
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.
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
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%).
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.