Stratos LV/LV-T Technical Manual 47

1.7.3AVAIL and OVID Combined Primary Endpoint-Complication-free Rate (Safety)

The results from for the AVAIL CLS/CRT and OVID studies were pooled to evaluate the safety of the Stratos LV device. 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, 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%.

Twenty-three (23) complications in these categories were seen in 21 patients with cumulative implant duration of 127.7 years. 12.8% of the patients had a reported complication in these categories. The rate of complications per patient-year was 0.18. Details of the Stratos LV complications in the AVAIL CLS/CRT and OVID studies are listed in Table 12.

Table 12: OVID and AVAIL Complication-Free

Rate - Stratos LV

 

 

Number

% of

Number of

Complications

 

 

Category

of

per patient-

 

 

Patients

Complications

 

 

 

Patients

year

 

 

 

 

 

 

 

LV Lead-Related

 

 

 

High

 

1.8%

 

 

 

 

Threshold / No

3

3

0.02

 

 

Capture

 

 

 

 

 

 

Diaphragmatic

2

1.2%

2

0.02

 

 

Stimulation

 

 

 

 

 

 

 

 

Dislodgement

1

1.2%

2

0.01

 

 

Total

7

4.3%

7

0.06

 

 

 

RV Lead Related

 

 

 

High

 

 

 

 

 

 

Threshold / No

9

5.5%

9

0.07

 

 

Capture

 

 

 

 

 

 

Total

9

5.5%

9

0.07

 

 

 

Atrial Lead Related

 

 

 

No Capture

1

0.6%

1

0.01

 

 

Total

1

0.6%

1

0.01