S-ICD® System IDE Clinical Study

This clinical study is a prospective, non-randomized, multicenter clinical study without a
control group conducted in the United States, Europe, and New Zealand.

Patients meeting eligibility criteria for implanting an S-ICD System will be enrolled in
this clinical study, implanted with an S-ICD System, and followed prior to hospital
discharge, and post-implant at 30 days, 90 days, and 180 days. After the 180-day
post-implant follow-up visit, patients will continue to be followed semi-annually until
study closure.

Eligible patients enrolled in this clinical study may also participate in the chronic
conversion sub-study.

The safety endpoint will be evaluated through the use of a 180-day S-ICD System
complication-free rate. The effectiveness endpoint will be evaluated using an induced
ventricular fibrillation (VF) conversion efficacy rate. Spontaneous episodes and chronic
conversion testing data will be evaluated using descriptive statistics to provide additional
data supporting the continued chronic performance of the S-ICD System.