Estella Pulse Generators - BIOTRONIK USA - News

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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
Estella Pulse Generators Technical Manual 33Time from Event Onset toEvaluation of First Event/PatientGroup 1N=972Group 2N=471p valueVF1.010.5 +/- 22.20145236 (24.3%)SVT2.016.6 ± 27.4010894 (9.7%)MedianMean ± SD (days)MinMax# of patients with events35.545.0 +/- 47.0028792 (19.5%)p < 0.001p < 0.001MedianMean ± SD (days)MinMax# of patients with events39.042.1 ± 35.6015735 (7.4%)p < 0.001p < 0.001Figure 4: Median Time from Onset to Evaluation of Arrhythmic EventsAnalysisThe mean time from onset to evaluation of first AF, VT, and VF events inGroup 2 is greater than the mean time from onset to evaluation of firstAF, VT, or VF events in Group 1. A rejection of the null hypothesis forAF, VT and VF event types indicates that the mean time from onset toevaluation of the first AF, VT and VF events in Group 1 is significantly lessthan the mean time from onset to evaluation of the first AF, VT and VFevents in Group 2. P-values are =0.005,
Page 1 and 2: BIOTRONIKEstella Pulse GeneratorsTe
Page 3 and 4: ContentsEstella Pulse Generators Te
Page 5 and 6: Estella Pulse Generators Technical
Page 9 and 10: 1. Device DescriptionEstella Pulse
Page 11 and 12: 2. IndicationsEstella Pulse Generat
Page 15 and 16: 4. Warnings and PrecautionsEstella
Page 25 and 26: 5. Adverse EventsNOTE:Estella Pulse
Page 35 and 36: 6.2.4 Clinical Study ConclusionsEst
Page 39: Estella Pulse Generators Technical
Page 49 and 50: 6.4.4.7 Additional Study ResultsEst
Page 53 and 54: 7. Programmable ParametersEstella P
Page 57 and 58: 7.2.3 Scan HysteresisEstella Pulse
Page 65 and 66: 7.5.3.2 AV HysteresisEstella Pulse
Page 71 and 72: Figure 13: Automatic Sensor GainEst
Page 73 and 74: Table 20: Rate DecreaseDecrease inR
Page 77 and 78: 7.11.2.1 PMT Detection and Terminat
Page 79 and 80: Table 21: Acronyms and TermsCVATMTe
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9. Other Functions/FeaturesEstella
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10. Product Storage and Handling10.
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11. Lead ConnectionEstella Pulse Ge
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12. Follow-up Procedures12.1 Genera
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Table 33: Nominal Pulse Generator L
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14. ExplantationEstella Pulse Gener
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AV Repetitive Hysteresis (Dual cham
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Periodic TransmissionOff, 30, 60, 9
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ParameterEstella Pulse Generators T
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16. Order InformationPulse Generato
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The AAI mode is conditionally indic
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Manufactured by:BIOTRONIK SE & Co.
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