Vagus Nerve Stimulators (VNS) – Pipeline Products by Stage of Development 12
Vagus Nerve Stimulators (VNS) – Pipeline Products by Territory 13
Vagus Nerve Stimulators (VNS) – Pipeline Products by Regulatory Path 14
Vagus Nerve Stimulators (VNS) – Pipeline Products by Estimated Approval Date 15
Vagus Nerve Stimulators (VNS) – Ongoing Clinical Trials 16
Vagus Nerve Stimulators (VNS) Companies – Pipeline Products by Stage of Development 17
Vagus Nerve Stimulators (VNS) – Pipeline Products by Stage of Development 19
Adriakaim Inc Pipeline Products & Ongoing Clinical Trials Overview 21
Vagus Nerve Stimulation Device – Product Status 21
Vagus Nerve Stimulation Device – Product Description 21
Afferent Technologies Pipeline Products & Ongoing Clinical Trials Overview 22
WiNerve4 System – Product Status 22
WiNerve4 System – Product Description 22
Aucta Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 23
DECIMA Device – Product Status 23
DECIMA Device – Product Description 23
Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 24
AMT System – Product Status 24
AMT System – Product Description 24
Vagus Nerve Stimulation (VNS) System – Product Status 25
Vagus Nerve Stimulation (VNS) System – Product Description 25
Cala Health Inc Pipeline Products & Ongoing Clinical Trials Overview 26
Wearable Neuromodulation Device – Product Status 26
Wearable Neuromodulation Device – Product Description 26
CerboMed GmbH Pipeline Products & Ongoing Clinical Trials Overview 27
t-VNS – Dementia – Product Status 27
t-VNS – Dementia – Product Description 27
Cyberonics Inc Pipeline Products & Ongoing Clinical Trials Overview 28
Nerve Wrap – Product Status 28
Nerve Wrap – Product Description 28
DuoCure Ltd. Pipeline Products & Ongoing Clinical Trials Overview 29
Intraluminal Implantable Device – Product Status 29
Intraluminal Implantable Device – Product Description 29
ElectroCore Inc Pipeline Products & Ongoing Clinical Trials Overview 30
ElectroCore RMS-1100 Resolution Motility System – Post-Operative Ileus – Product Status 31
ElectroCore RMS-1100 Resolution Motility System – Post-Operative Ileus – Product Description 31
GammaCore – Gastroparesis – Product Status 31
GammaCore – Gastroparesis – Product Description 32
GammaCore – Opioid Use Disorder – Product Status 32
GammaCore – Opioid Use Disorder – Product Description 32
GammaCore – Parkinsonian Gait – Product Status 33
GammaCore – Parkinsonian Gait – Product Description 33
GammaCore – Post-Traumatic Headache – Product Status 33
GammaCore – Post-Traumatic Headache – Product Description 34
GammaCore – Post-Traumatic Stress Disorder – Product Status 34
GammaCore – Post-Traumatic Stress Disorder – Product Description 34
Gammacore – Reactive Airway Disease – Product Status 35
Gammacore – Reactive Airway Disease – Product Description 35
GammaCore – Rheumatoid Arthritis – Product Status 35
GammaCore – Rheumatoid Arthritis – Product Description 36
GammaCore – Sjogren’s Syndrome – Product Status 36
GammaCore – Sjogren’s Syndrome – Product Description 36
GammaCore – Stroke – Product Status 37
GammaCore – Stroke – Product Description 37
GammaCore – Subarachnoid Hemorrhage – Product Status 37
GammaCore – Subarachnoid Hemorrhage – Product Description 38
GammaCore – Traumatic Brain Injury – Product Status 38
GammaCore – Traumatic Brain Injury – Product Description 38
GammaCore – Ulcerative Colitis – Product Status 39
GammaCore – Ulcerative Colitis – Product Description 39
GammaCore Sapphire – Post-Traumatic Headache – Product Status 39
GammaCore Sapphire – Post-Traumatic Headache – Product Description 40
GammaCore Sapphire CV – Product Status 40
GammaCore Sapphire CV – Product Description 40
Resolve Stimulator and Proximity Electrode – Product Status 41
Resolve Stimulator and Proximity Electrode – Product Description 41
ElectroCore Inc – Ongoing Clinical Trials Overview 42
GammaCore – Gastroparesis – Non-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients with Gastroparesis and Related Disorders 43
GammaCore Sapphire CV – A Prospective, Randomized, Controlled Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (SAVIORII) 44
GammaCore Sapphire – Post-Traumatic Headache – A Randomized, Multi-center, Double-blind, Sham-controlled Study of GammaCore Sapphire for the Treatment of Patients with Post-traumatic Headache 45
ElectroCore RMS-1100 Resolution Motility System – Post-Operative Ileus – Transcutaneous Vagal Nerve Stimulation to Reduce Ileus: A Feasibility Study (TRANSIT) 46
GammaCore – Post-Traumatic Stress Disorder – Transcutaneous Cervical Vagal Nerve Stimulation in Patients with Posttraumatic Stress Disorder (PTSD): A Pilot Study of Effects on PTSD Symptoms and Interleukin-6 Response to Stress 47
GammaCore – Subarachnoid Hemorrhage – Safety and Efficacy of Non-invasive Vagus Nerve Stimulation in the Treatment of Headache in Subarachnoid Hemorrhage 48
GammaCore – Subarachnoid Hemorrhage – Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage: STORM 48
GammaCore – Opioid Use Disorder – Non-Invasive Vagal Nerve Stimulation in Opioid Use Disorders 49
GammaCore – Traumatic Brain Injury – Non-Invasive Vagal Nerve Stimulation in Veterans with Mild Traumatic Brain Injury (mTBI) 50
Evren Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 51
Phoenix Earbud Device – Product Status 51
Phoenix Earbud Device – Product Description 51
Flint Rehabilitation Pipeline Products & Ongoing Clinical Trials Overview 52
FitMi VNS System – Product Status 52
FitMi VNS System – Product Description 52
FRD Accel LLC Pipeline Products & Ongoing Clinical Trials Overview 53
BabyStrong TaVNS Bottle Feeding System – Product Status 53
BabyStrong TaVNS Bottle Feeding System – Product Description 53
LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 54
Aspire NP – Product Status 54
Aspire NP – Product Description 55
Centro Generator – Product Status 55
Centro Generator – Product Description 55
CentroSR Generator – Product Status 56
CentroSR Generator – Product Description 56
EpiTrace – Product Status 56
EpiTrace – Product Description 56
Equilia – Product Status 57
Equilia – Product Description 57
Griffin – Pulse Generator – Product Status 57
Griffin – Pulse Generator – Product Description 58
Intense Neuromodulation System – Heart Failure – Product Status 58
Intense Neuromodulation System – Heart Failure – Product Description 58
Microburst VNS Stimulator – Product Status 58
Microburst VNS Stimulator – Product Description 59
PhoenixRF SR – Product Status 59
PhoenixRF SR – Product Description 59
VITARIA System – Chronic Heart Failure – Product Status 60
VITARIA System – Chronic Heart Failure – Product Description 60
WaveLink – Product Status 60
WaveLink – Product Description 61
LivaNova PLC – Ongoing Clinical Trials Overview 62
VITARIA System – Chronic Heart Failure – Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure with Reduced Ejection Fraction 63
Microburst VNS Stimulator – Microburst VNS Therapy Feasibility Study in Subjects with Refractory Epilepsy 64
Medical University of South Carolina Pipeline Products & Ongoing Clinical Trials Overview 65
BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) – Product Status 65
BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) – Product Description 65
Medical University of South Carolina – Ongoing Clinical Trials Overview 66
BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) – BabyStrong taVNS-Paired Bottle Feeding to Improve Oral Feeding 67
MicroTransponder Inc Pipeline Products & Ongoing Clinical Trials Overview 68
SAINT System – Anxiety Disorders – Product Status 68
SAINT System – Anxiety Disorders – Product Description 68
SAINT System – Tinnitus – Product Status 69
SAINT System – Tinnitus – Product Description 69
Serenity System – Product Status 69
Serenity System – Product Description 70
Vivistim Paired VNS System – Product Status 70
Vivistim Paired VNS System – Product Description 71
MicroTransponder Inc – Ongoing Clinical Trials Overview 72
Vivistim Paired VNS System – A Pivotal Randomized Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function after Stroke: VNS-REHAB 73
Vivistim Paired VNS System – Vivistim Registry for Paired VNS Therapy (GRASP) 73
Nemechek Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 74
Vitality Smartcable – COVID-19 – Product Status 74
Vitality Smartcable – COVID-19 – Product Description 74
Neuroloop Gmbh Pipeline Products & Ongoing Clinical Trials Overview 75
Neurostimulation System – Product Status 75
Neurostimulation System – Product Description 75
Nexeon MedSystems Inc Pipeline Products & Ongoing Clinical Trials Overview 76
Auricular Vagus Nerve Stimulator – Asthma – Product Status 76
Auricular Vagus Nerve Stimulator – Asthma – Product Description 76
aVNS Device – Product Status 77
aVNS Device – Product Description 77
Vagus Nerve Stimulator – Asthma – Product Status 77
Vagus Nerve Stimulator – Asthma – Product Description 78
Otto Bock HealthCare GmbH Pipeline Products & Ongoing Clinical Trials Overview 79
Neuromodulation Device – Epilepsy – Product Status 79
Neuromodulation Device – Epilepsy – Product Description 79
Neuromodulation Device – Sleep Apnea – Product Status 80
Neuromodulation Device – Sleep Apnea – Product Description 80
Parasym Ltd Pipeline Products & Ongoing Clinical Trials Overview 81
Parasym Device – Product Status 81
Parasym Device – Product Description 81
Parasym Ltd – Ongoing Clinical Trials Overview 82
Parasym Device – Multimodal Investigation of Post COVID-19 in Females: A Pilot Study 83
Parasym Device – Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis 83
Parasym Device – Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes (NoVa-PVC) 83
Parasym Device – The Effect of Different Low-level Tragus Stimulation Parameters on Autonomic Nervous System Function 84
Parasym Device – Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery: The TraP-AF Study 84
Pulsetto UAB Pipeline Products & Ongoing Clinical Trials Overview 85
Vagus Nerve Stimulator – Product Status 85
Vagus Nerve Stimulator – Product Description 85
Pulsus Medical LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 86
VNS Device – Product Status 86
VNS Device – Product Description 86
Purdue University Pipeline Products & Ongoing Clinical Trials Overview 87
Bionode Device – Product Status 87
Bionode Device – Product Description 87
ReShape Lifesciences Inc Pipeline Products & Ongoing Clinical Trials Overview 88
Diabetes Bloc-Stim Neuromodulation Device – Product Status 88
Diabetes Bloc-Stim Neuromodulation Device – Product Description 88
Setpoint Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 89
Implantable Bioelectronic Device – Product Status 89
Implantable Bioelectronic Device – Product Description 89
Setpoint Medical Corp – Ongoing Clinical Trials Overview 90
Implantable Bioelectronic Device – Long Term Extension Study of the Safety and Efficacy of Neurostimulation Using a Vagus Nerve Stimulation Device in Patients with Rheumatoid Arthritis 91
Implantable Bioelectronic Device – US Pivotal Trial Evaluate the Safety and Efficacy of Bioelectronic Platform in Rheumatoid Arthritis Patients 91
Implantable Bioelectronic Device – Vagus Nerve Stimulation Using the SetPoint System for Moderate to Severe Rheumatoid Arthritis: The RESET-RA Study 91
Soterix Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 92
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Device – Product Status 92
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Device – Product Description 92
Soterix Medical Inc – Ongoing Clinical Trials Overview 93
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Device – Clinical Trial Evaluating the Efficacy of Home-based Auricular Vagus Nerve Stimulation (taVNS) in Post-COVID-19 Subjects 94
SUNY Downstate Medical Center Pipeline Products & Ongoing Clinical Trials Overview 95
Vagus Nerve Stimulator – Ventricular Arrhythmia – Product Status 95
Vagus Nerve Stimulator – Ventricular Arrhythmia – Product Description 95
Synergia Medical SA Pipeline Products & Ongoing Clinical Trials Overview 96
NAO·VNS – Chronic Pain – Product Status 96
NAO·VNS – Chronic Pain – Product Description 96
NAO·VNS – Depression – Product Status 97
NAO·VNS – Depression – Product Description 97
NAO·VNS – Epilepsy – Product Status 97
NAO·VNS – Epilepsy – Product Description 98
NAO·VNS – Parkinson’s Disease – Product Status 98
NAO·VNS – Parkinson’s Disease – Product Description 98
NAO·VNS – Sleep Apnoea – Product Status 99
NAO·VNS – Sleep Apnoea – Product Description 99
SzeleSTIM GmbH Pipeline Products & Ongoing Clinical Trials Overview 100
AuriMod – Product Status 100
AuriMod – Product Description 100
SzeleSTIM GmbH – Ongoing Clinical Trials Overview 101
AuriMod – Personalized Auricular Vagus Nerve Stimulation in Patients with Intractable Chronic Low Back Pain: A Randomized Controlled Pilot Study 102
The Feinstein Institute for Medical Research Pipeline Products & Ongoing Clinical Trials Overview 103
Bioelectronic Medicine Device – Heart Failure – Product Status 103
Bioelectronic Medicine Device – Heart Failure – Product Description 103
Bioelectronic Medicine Device – Lupus – Product Status 104
Bioelectronic Medicine Device – Lupus – Product Description 104
Bioelectronic Medicine Device – Obesity – Product Status 104
Bioelectronic Medicine Device – Obesity – Product Description 105
Bioelectronic Medicine Device – Pulmonary Hypertension – Product Status 105
Bioelectronic Medicine Device – Pulmonary Hypertension – Product Description 105
Neurochip – Product Status 106
Neurochip – Product Description 106
Trifectas Medical Corp. Pipeline Products & Ongoing Clinical Trials Overview 107
Neurostimulation Device – Stroke Recovery – Product Status 107
Neurostimulation Device – Stroke Recovery – Product Description 107
University of Alabama Pipeline Products & Ongoing Clinical Trials Overview 108
VNS Device – Depression – Product Status 108
VNS Device – Depression – Product Description 108
University of Auckland Pipeline Products & Ongoing Clinical Trials Overview 109
Electroceutical Device – Product Status 109
Electroceutical Device – Product Description 109
University of Pittsburgh Pipeline Products & Ongoing Clinical Trials Overview 110
Closed-Loop Neuroelectric Device – Product Status 110
Closed-Loop Neuroelectric Device – Product Description 110
University of Wisconsin Madison Pipeline Products & Ongoing Clinical Trials Overview 111
Implantable Weight-Loss Device – Product Status 111
Implantable Weight-Loss Device – Product Description 111
Glossary 133