Estella Pulse Generators - BIOTRONIK USA - News

32 Estella Pulse Generators Technical ManualAnalysisThe safety event rate for a 12-month duration was 14.8% for Group 1(HM) and 16.4% for Group 2 (Control), with a non‐inferiority p-value of0.005. Therefore, the safety event rate for HM Group was non-inferiorto the safety event rate for the Control Group within 5%. The upper,one‐sided 95% confidence bound for the difference was 2.7%.A rejection of the null hypothesis indicates that the safety event rate forGroup 1 (HM) is equivalent (non-inferior) to that of Group 2 (Control).6.3.3.3 Secondary Endpoint 1: Early Detection of CardiacEvents (AF, VT & VF)The purpose of secondary endpoint 1 was to compare AF, VT and VFevents between Group 1 and Group 2 in terms of the number, categories,and detection time relative to onset.Table 8 compares the time from onset to evaluation of the first AF, VTand VF events for each patient that have occurred in each group, as wellas the first of any type of event for each patient in each group. Figure 4illustrates the time from onset to evaluation of arrhythmic events in aboxplot graph.Table 8: Time from First Event Onset to EvaluationTime from Event Onset toEvaluation of First Event/PatientMedianMean ± SD (days)MinMax# of patients with eventsMedianMean ± SD (days)MinMax# of patients with eventsGroup 1N=972AF5.025.2 +/- 34.2017173 (7.5%)VT1 & VT22.012.9 +/- 33.80256149 (15.3%)Group 2N=47139.546.8 +/- 33.7111428 (5.9%)32.046.6 +/- 46.9024553 (11.2%)p valuep < 0.001p = 0.005p < 0.001p < 0.001