Stratos LV/LV-T Technical Manual 43

Safety and Effectiveness Results

•The cumulative implant duration was 760 months with a mean duration of 9.2 months. Sixty-five (77%) of the patients had implant durations greater than 6 months.

•The implant success rate for the Stratos LV CRT-P was

100% (89 out of 89). The implant success of the Stratos LV CRT-P in combination with the Corox OTW/Steroid LV lead was 94.4% (84 out of 89).

•The mean LV pacing threshold at implant was 0.9 and at 6-months was 0.9 volts.

•The mean R-wave at implant was 15.7 mV.

•The mean LV lead impedance at implant was 729 ohms and at 6-months was 603 ohms.

•There were 29 adverse events (18 observations in 17 patients and 11 complications in 10 patients). There were no unanticipated adverse device effects reported.

•There were 10 patient deaths reported in the OVID study. The clinical investigators have determined that no deaths were related to the Stratos LV CRT-P system.

•The overall follow-up compliance rate for the OVID study is 93%.

Primary Endpoint—Complication-free Rate (Safety)

The safety of the Stratos LV was evaluated based on complications (adverse events that require additional invasive intervention to resolve) related to the implanted CRT system which includes the Stratos LV device, the atrial lead, the right ventricular lead, the left ventricular lead and the implant procedure. The target complication-free rate at six months was 85%.

Ten (10)

complications in

these categories were seen in

10 patients

with cumulative

implant duration of 760 months

(63.3 patient-years). 11.2% of the patients had a reported complication in these categories. The rate of complications per patient-year was 0.16. Details of the Stratos LV complications in the OVID study are listed in Table 10.