BIOTRONIK Evia DR, Technical Manual

Page: 3 / 183

Evia Technical Manual i
Contents
1. Device Description .......................................................... 1
2. Indications ........................................................................ 4
3. Contraindications ............................................................ 6
4. Warnings and Precautions ............................................. 8
4.1 Medical Therapy .......................................................... 8
4.2 Storage and Sterilization ........................................... 10
4.3 Lead Connection and Evaluation .............................. 10
4.4 Programming and Operation ..................................... 12
4.5 Home Monitoring ....................................................... 14
4.6 Electromagnetic Interference (EMI) .......................... 15
4.6.1 Home and Occupational Environments ............... 16
4.6.2 Cellular Phones .................................................... 17
4.6.3 Hospital and Medical Environments .................... 18
4.7 Pulse Generator Explant and Disposal ..................... 19
5. Adverse Events .............................................................. 21
5.1 Observed Adverse Events ......................................... 21
5.1.1 Dromos DR Clinical Study ................................... 21
5.1.2 PACC Clinical Study ............................................ 23
5.1.3 Inos2+ CLS Clinical Study ................................... 24
5.2 Potential Adverse Events .......................................... 26
6. Clinical Study ................................................................. 27
6.1 Dromos DR ................................................................ 27
6.2 Ventricular Capture Control ....................................... 28
6.2.1 Primary Objectives ............................................... 29
6.2.2 Methods ............................................................... 29
6.2.3 Results ................................................................. 29
6.2.4 Clinical Study Conclusions ................................... 34
6.3 Closed Loop Stimulation (CLS) ................................. 35
6.3.1 Protos DR/CLS Response to Mental Stress ........ 35
6.3.2 Protos DR CLS with AxVx .................................... 38
6.3.3 Inos
2+
CLS ............................................................ 41
6.4 TRUST Clinical Study ................................................ 44
6.4.1 Study Overview .................................................... 44
6.4.2 Methods ............................................................... 45
6.4.3 Summary of Clinical Results ................................ 47