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.
Pace/Sense Mode VVI ;
Right Ventricle Pulse Width 0.4 ms;
Lower Pace Rate 60 bpm;
Right Ventricle Percent Paced 100 %;
Upper Sensing Rate 130 ppm;
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Distribution Data
US Market Release
2017-08-03
CE Approval Date
2017-06-16
Registered USA Implants
Estimated Active USA Implants
Normal Battery Depletions
US Market Release
2017-08-03
CE Approval Date
2017-06-16
Estimated WW Distribution
18129
Normal Battery Depletions
Malfunctions (USA)
Therapy Function Not Compromised
Therapy Function Compromised
Malfunctions (WW)
Therapy Function Not Compromised
Therapy Function Compromised
EOL Indicator
180 days from RRT
Recommended Replacement (RRT)
Battery voltage less than or equal to 2.5 V, or battery voltage less than or equal to 2.59 V and battery impedance at 3000 ohms
