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.
Pacing Mode VVI; Ventricular Lower Pacing Rate 60ppm;Ventricular Pulse Width 0.4ms; Ventricular Pulse Amplitude 2V; Ventricle Impedance 500ohms; Ventricle Sensing Rate 70bpm; EGM ON; Charging frequency assumes maximum energy charge and includes therapy shocks and capacitor formation.Hide this content
Distribution Data
US Market Release
2020-04-23
CE Approval Date
2019-12-18
Registered USA Implants
1680
Estimated Active USA Implants
1578
Normal Battery Depletions
2
US Market Release
2020-04-23
CE Approval Date
2019-12-18
Estimated WW Distribution
11188
Normal Battery Depletions
2
Malfunctions (USA)
Therapy Function Not Compromised
Therapy Function Compromised
Malfunctions (WW)
Therapy Function Not Compromised
Therapy Function Compromised
EOS Indicator
From the point that the RRT is set, the pacemaker will operate for approximately three months for typical pacemaker configurations during the normal operating life.
Recommended Replacement (RRT)
Battery voltage less than or equal to 2.8 V on 3 consecutive daily automatic measurements.
