Proven Performance

S-ICD

Extensive clinical studies have shown that S-ICD offers proven performance for most patients at risk of sudden cardiac death, allowing you to use the features you want without sacrificing device longevity.1-8

This is demonstrated with the EMBLEM™ S-ICD, projected to deliver 8.7 years of use in the real world – with all features turned on.9

Directions for Use S-ICD Evolution Brochure
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Low need for Brady/ATP

S-ICD is recommended for most ICD-indicated patients, without the need for pacing, in the following guidelines:

  • Class I, 2017 AHA/ACC/HRS Guidelines2
  • Class IIa, 2017 AHA/ACC/HRS and 2015 ESC Guidelines2,3

 

Although S-ICD lacks Brady pacing and ATP functionality, there is relatively low demand for these in patients with an ICD indication receiving an S-ICD6,8,10-12

Patient Demographic
Empower

The MODULAR ATP study, which is currently enrolling patients, is designed to demonstrate the safety, performance and effectiveness of the mCRM™ System (EMBLEM™ S-ICD System and EMPOWER™ Modular Pacing System) for those few patients who may need Brady pacing or ATP at implant, or may develop a need in the future.

All EMBLEM™ S-ICDs are, by design, compatible with the EMPOWER™ Leadless Pacemaker*.

 

 

Real-World Data

Implantation technique

RHYTHM DETECT

 

 

In the RHYTHM DETECT real-world study, intermuscular generator implantation using the 2‐incision technique resulted in lower PRAETORIAN Score**, lower shock impedance, and higher defibrillation success than the traditional subcutaneous, 3-incision implantation technique13,14
Conversion rate
 
S-ICD systems implanted using modern surgical techniques, demonstrated a high safety defibrillation margin (40-J)15
 
Pie Charts
Placing the S-ICD generator in the intermuscular space, instead of a subcutaneous pocket, resulted in fewer device-related complications and inappropriate shocks over a medium-term follow-up16

 

 

Optimised programming

The “UNTOUCHED-like” programming‡, with high-rate cut-offs for discrimination, reduced the rate of inappropriate shock in the S-ICD population without impacting therapy effectiveness (3.0% vs 4.6%)17..

 

 

Long-term use

The HONEST independent cohort study, supported long-term S-ICD use in a real-world setting, with 4,924 patients enrolled across 150 centres in France.12

Similar to the PRAETORIAN Trial, S-ICDs enrolled in the HONEST cohort demonstrated high efficacy, low rates of complications, as well as low inappropriate shock rates; in long-term real-world settings, in a varied patient cohort.

 

 

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