4195
Attain StarFix
ALL

Device Survival Probability
4195_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 | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.1 | 98.5 | 98.1 | 97.6 | 97.2 | 96.8 | 96.4 | 95.6 | 95.2 | 95.2 | 94.3 | ||||||||||
# | 1243 | 1072 | 924 | 746 | 614 | 502 | 391 | 275 | 187 | 114 | 54 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1486 |
---|---|
Cumulative Months of Follow-Up | 82057 |
Number of Leads Active in Study | 256 |

US Acute Lead Observations
Extra Cardiac Stimulation | 30 |
---|---|
Failure to Capture | 21 |
Impedance Out of Range | 4 |
Lead Dislodgement | 30 |
Unspecified Clinical Failure | 1 |

Product Characteristics
Lead Type | Left-Heart |
---|---|
Type and/or Fixation | Deployable Lobe Fixation |
Lead Function | Pacing/Sensing |
Lead Placement | Transvenous |
Lead Tip Location | Left Ventricular Cardiac Vein |
Pace/Sense Polarity | Unipolar |
Serial Number Prefix | AAD |
---|---|
Lead Body Diameter | 5.0 FR |
Insulation | Polyurethane |
Pace/Sense Connector Style | IS-1 UNI |
High Voltage Connector | n/a |
Steroid | Yes |
Data as of December 16, 2021