Mintek LV User Manual

Stratos LV/LV-T Technical Manual  i 

 

 

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

 

1.7.3

 

AVAIL 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

 

 

 

2.1

 

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