S-ICD System

Subcutaneous Implantable Defibrillator

Innovation Backed by Evidence

Three important clinical studies have been instrumental in demonstrating the S-ICD System as a compelling solution for the prevention of sudden cardiac death in a broad range of patients.

2-year Results from a POOLED Analysis of the IDE Study and EFFORTLESS Registry (Published in JACC in early 2015)1

• 882 patients, Average Follow-Up: 651 days
• Largest patient cohort, most comprehensive data and longest follow-up period further demonstrates the worldwide safety and efficacy of the S-ICD System in a large diverse population
• Combining the studies provides a unique opportunity to evaluate:
   - Complications
   - Spontaneous events

US IDE Study (Published in CirculaIon 2013)2

• 321 patients, Average Follow-Up: 11 months
• Completed in 2011 and was the cornerstone for US FDA approval
• Primary Safety Endpoint: 180-Day S-ICD System Complication Free Rate compared to prespecified goal of 79 %
• Primary Efficacy Endpoint: Induced VF conversions of 4 attempts compared with prespecified goal of 88 %

EFFORTLESS Registry Interim Results (Published in European Heart Journal in early 2014)3

• 456 patients, Average Follow-Up: 558 days
• Ongoing Registry In Europe and New Zealand
• Primary Outcome Measures:
   - Perioperative S-ICD System Complication Free Rate
   - 360 Day S-ICD System Complication Free Rate
• Inappropriate shocks for AF / SVT

The S-ICD System has been implanted in a BROAD RANGE OF PATIENTS

POOLED Study Implanted Patients (n = 882)
Demographic N (%)
Age (years) 50.3 ± 16.9*
Male 636 (72.5 %)
Ischemic 330 (37.8 %)
Genetic 58 (6.7 %)
Idiopathic VF 40 (4.6 %)
Channelopathies 90 (10.3 %)
NYHA Classification II-IV 327 (37.5 %)
Arial Fibrillation 143 (16.4 %)
Previous Defibrillator 120 (13.7 %)

43 % of the study population were primary prevention patients with an EF ≤ 35 % 1

Data has demonstrated a SAFE solution for sudden cardiac death



Electrode Failures, Systemic Blood Infections, Endocarditis or Cardiac Injuries

The lack of problematic consequences of endovascular complications including systemic infections could be a factor in the observed low mortality rate (Tarakji KG et al Europace 2014).

In the IDE Study, there were no explants due to infection in the last 2 / 3 implantations.

Inappropriate Therapy

34 % reduction with a 4.5 % incidence of IAS at 6 months1

Data has demonstrated an EFFECTIVE solution for sudden cardiac arrest

Conversion Efficacy of Induced Arrhythmias


The S-ICD System consistently demonstrates effective conversions of induced arrhythmias.

Conversion Efficacy of Discrete Spontaneous Arrhythmias

98.2 %1

Clinical conversion of spontaneous arrhythmias was achieved in all patients.

First Shock Efficacy

91.1 %1

The S-ICD System first shock
conversion efficacy is in line with
rates published for TV-ICDs.3