Stratos LV/LV-T Technical Manual i

Contents

 

1. General ..............................................................................

1

1.1

Device Description ........................................................

1

1.2

Indications .....................................................................

2

1.3

Contraindications ..........................................................

3

1.4

Note to Physician ..........................................................

3

1.5

Warnings and Precautions ............................................

3

1.5.1

Interactions with Other Medical Therapy...............

4

1.5.2

Storage and Sterilization .......................................

6

1.5.3

Lead Connection and Evaluation ..........................

7

1.5.4

Programming and Operation.................................

8

1.5.5

Home Monitoring .................................................

11

1.5.6

Electromagnetic Interference (EMI) ....................

13

1.5.7

Home and Occupational Environments...............

13

1.5.8

Cellular Phones ...................................................

14

1.5.9

Hospital and Medical Environments....................

15

1.5.10

Device Explant and Disposal...............................

15

1.6

Potential Effects of the Device on Health....................

16

1.7

Clinical Studies............................................................

17

1.7.1

Stratos LV Clinical Study – AVAIL CLS/CRT ......

17

1.7.2

Stratos LV Clinical Study – OVID study ..............

39

1.7.3AVAIL and OVID Combined Primary

 

Endpoint-Complication-free Rate (Safety) ..........

47

1.7.4

Tupos LV/ATx Clinical IDE Study -

 

 

OPTION CRT/ATx...............................................

49

1.7.5

Conclusions Drawn from Studies ........................

61

2. Programmable Parameters............................................

63

2.1 Pacing Modes..............................................................

63

2.1.1

Rate-adaptive Modes ..........................................

63

2.1.2

DDD.....................................................................

63

2.1.3

DDI ......................................................................

67

2.1.4

DVI.......................................................................

67

2.1.5

VDD .....................................................................

67

2.1.6

AAI and VVI .........................................................

68

2.1.7

AAI, VVI ...............................................................

68

2.1.8

AOO, VOO...........................................................

68

2.1.9

DOO ....................................................................

68

2.1.10

VDI.......................................................................

68