Boston Scientific Corporation CRMA20914 User Manual
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Safety and Effectiveness Results
Safety Results
The 180-day Type I complication-free rate was assessed in all patients with an attempted S-ICD System implant (N=321) for
The 180-day Type I complication-free rate was assessed in all patients with an attempted S-ICD System implant (N=321) for
the primary safety endpoint. A Type I complication was defined as any clinical event caused by the S-ICD System that required
invasive intervention.
The Type I complication-free rate at 180 days was 99.0% with a lower 95% confidence bound of 97.9%. These results meet
The Type I complication-free rate at 180 days was 99.0% with a lower 95% confidence bound of 97.9%. These results meet
the primary safety endpoint performance goal of 79% and demonstrate the safety of the S-ICD System. Details of the Kaplan-
Meier analysis are shown in Figure 2 and Table 5.
Figure 2: Primary Safety Endpoint Kaplan-Meier Analysis