Including Normal Battery Depletion – This curve includes devices that have reached at least 80% of expected longevity. This curve is most representative of clinical performance and how long the device will last.
Excluding Normal Battery Depletion – This is the malfunction free survival curve.
Longevity estimates based on the following device usage.
Pacing Mode DDD;
Atrial Lower Pacing Rate 60ppm;
Ventricular Lower Pacing Rate 60ppm;
Atrial Pulse Width 0.4ms;
Ventricular Pulse Width 0.4ms;
Atrial Pulse Amplitude 3V;
Ventricular Pulse Amplitude 3V;
Atrial Impedance 510ohms;
Ventricle Impedance 510ohms;
Atrial Sensing Rate 70bpm;
Ventricle Sensing Rate 70bpm;
EGM prestorage OFF;
Atrial Fib percentage of time 0%;
Charging frequency assumes maximum energy charge and includes therapy shocks and capacitor formation.
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EOS device status is defined as 3 months following an RRT indication
assuming the following PSP conditions: 100% DDD pacing at 60 bpm, 2.5 V, 0.4 ms; 500 Ohm pacing load; and
6 full-energy charges. EOS may be indicated before the end of 3
months if the device exceeds these conditions.