Subcutaneous ICD (S-ICD) Trials and Studies
2-year Results from a Pooled Analysis of the IDE Study and EFFORTLESS Registry
Combining these two studies provides a unique opportunity to evaluate complications as well as amass a significant number of spontaneous events in 882 implanted patients followed for 1,517 patient-years.
The EFFORTLESS S-ICD Registry is a non-randomized, standard of care, multicenter registry designed to collect long term system-related, clinical, and patient reported outcome data from S-ICD implanted patients since June 2009.
IDE Clinical Study
Prospective, Single-Arm Comparison to Objective Performance Criteria
Pre-market Investigational Device Exemption (IDE)