4076
CapSureFix Novus
VENTRICULAR PLACEMENT
Device Survival Probability
4076_VEN_SURV
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1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | 11 yr | 12 yr | 13 yr | 14 yr | 15 yr | 16 yr | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 99.7 | 99.7 | 99.7 | 99.6 | 99.3 | 99.3 | 99.0 | 99.0 | 98.8 | 98.5 | 98.5 | 98.5 | 98.1 | 98.1 | 98.1 | 96.7 | ||||||
# | 1451 | 1296 | 1145 | 985 | 785 | 672 | 564 | 485 | 421 | 350 | 283 | 228 | 191 | 131 | 91 | 59 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1770 |
---|---|
Cumulative Months of Follow-Up | 119246 |
Number of Leads Active in Study | 318 |
ATRIAL PLACEMENT
Device Survival Probability
4076_ATR_SURV
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1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | 11 yr | 12 yr | 13 yr | 14 yr | 15 yr | 16 yr | at 198.0 mo | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 99.7 | 99.6 | 99.6 | 99.5 | 99.4 | 99.0 | 98.9 | 98.8 | 98.8 | 98.8 | 98.5 | 98.5 | 98.2 | 97.2 | 97.2 | 97.2 | 97.2 | |||||
# | 3517 | 3022 | 2647 | 2298 | 1916 | 1650 | 1451 | 1266 | 1064 | 846 | 615 | 459 | 341 | 210 | 141 | 89 | 63 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 4928 |
---|---|
Cumulative Months of Follow-Up | 281736 |
Number of Leads Active in Study | 1759 |
US Acute Lead Observations
Cardiac Perforation | 261 |
---|---|
Conductor Fracture | 11 |
Extra Cardiac Stimulation | 27 |
Failure to Capture | 396 |
Failure to Sense | 288 |
Impedance Out of Range | 76 |
Insulation Breach | 2 |
Lead Dislodgement | 913 |
Oversensing | 150 |
Unspecified Clinical Failure | 10 |
Product Characteristics
Lead Type | Pacing |
---|---|
Type and/or Fixation | Active Screw In |
Lead Function | Pacing/Sensing |
Lead Placement | Transvenous |
Lead Tip Location | Atrium or Right Ventricle |
Pace/Sense Polarity | Bipolar |
Serial Number Prefix | BBL |
---|---|
Lead Body Diameter | 5.7 FR |
Insulation | Polyurethane/Silicone |
Pace/Sense Connector Style | IS-1 BI |
High Voltage Connector | n/a |
Steroid | Yes |
Data as of April 30, 2024