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
AURIMOD GmbH Pipeline Products & Ongoing Clinical Trials Overview 24
AuriMod – Product Status 24
AuriMod – Product Description 24
Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 25
AMT System – Product Status 25
AMT System – Product Description 25
Vagus Nerve Stimulation (VNS) System – Product Status 26
Vagus Nerve Stimulation (VNS) System – Product Description 26
Boston Scientific Corp – Ongoing Clinical Trials Overview 27
Vagus Nerve Stimulation (VNS) System – Neural Cardiac Therapy for Heart Failure Study 28
Cala Health Inc Pipeline Products & Ongoing Clinical Trials Overview 29
RAVANS Device – Product Status 29
RAVANS Device – Product Description 29
Wearable Neuromodulation Device – Product Status 30
Wearable Neuromodulation Device – Product Description 30
Cala Health Inc – Ongoing Clinical Trials Overview 31
RAVANS Device – Investigating the Safety and Efficacy of Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) in Ulcerative Colitis (UC) in Pediatric and Young Adult Populations 32
CerboMed GmbH Pipeline Products & Ongoing Clinical Trials Overview 33
t-VNS – Dementia – Product Status 33
t-VNS – Dementia – Product Description 33
Cyberonics Inc Pipeline Products & Ongoing Clinical Trials Overview 34
Nerve Wrap – Product Status 34
Nerve Wrap – Product Description 34
DuoCure Ltd. Pipeline Products & Ongoing Clinical Trials Overview 35
Intraluminal Implantable Device – Product Status 35
Intraluminal Implantable Device – Product Description 35
ElectroCore Inc Pipeline Products & Ongoing Clinical Trials Overview 36
ElectroCore RMS-1100 Resolution Motility System – Post-Operative Ileus – Product Status 36
ElectroCore RMS-1100 Resolution Motility System – Post-Operative Ileus – Product Description 37
GammaCore – Gastroparesis – Product Status 37
GammaCore – Gastroparesis – Product Description 37
GammaCore – Opioid Use Disorder – Product Status 38
GammaCore – Opioid Use Disorder – Product Description 38
GammaCore – Parkinsonian Gait – Product Status 38
GammaCore – Parkinsonian Gait – Product Description 39
GammaCore – Post-Traumatic Headache – Product Status 39
GammaCore – Post-Traumatic Headache – Product Description 39
GammaCore – Post-Traumatic Stress Disorder – Product Status 40
GammaCore – Post-Traumatic Stress Disorder – Product Description 40
Gammacore – Reactive Airway Disease – Product Status 40
Gammacore – Reactive Airway Disease – Product Description 41
GammaCore – Rheumatoid Arthritis – Product Status 41
GammaCore – Rheumatoid Arthritis – Product Description 41
GammaCore – Sjogren’s Syndrome – Product Status 42
GammaCore – Sjogren’s Syndrome – Product Description 42
GammaCore – Stroke – Product Status 42
GammaCore – Stroke – Product Description 43
GammaCore – Subarachnoid Hemorrhage – Product Status 43
GammaCore – Subarachnoid Hemorrhage – Product Description 43
GammaCore – Traumatic Brain Injury – Product Status 44
GammaCore – Traumatic Brain Injury – Product Description 44
GammaCore – Ulcerative Colitis – Product Status 44
GammaCore – Ulcerative Colitis – Product Description 45
gammaCore Sapphire – Product Status 45
gammaCore Sapphire – Product Description 45
Resolve Stimulator And Proximity Electrode – Product Status 46
Resolve Stimulator And Proximity Electrode – Product Description 46
ElectroCore Inc – Ongoing Clinical Trials Overview 47
gammaCore Sapphire – Non-invasive Vagus Nerve Stimulation in Acute Ischemic Stroke 48
gammaCore Sapphire – Vagus Nerve Stimulation as a Novel Treatment for Systemic Lupus Erythematous: A Double Blinded Randomized Controlled Trail 48
GammaCore – Gastroparesis – Non-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients with Gastroparesis and Related Disorders 49
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 50
GammaCore – Post-Traumatic Stress Disorder – Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder 50
GammaCore – Subarachnoid Hemorrhage – Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage: STORM 51
GammaCore – Opioid Use Disorder – Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3 52
GammaCore – Traumatic Brain Injury – Non-Invasive Vagal Nerve Stimulation in Veterans with Mild Traumatic Brain Injury (mTBI) 53
Evren Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 54
Phoenix Earbud Device – Product Status 54
Phoenix Earbud Device – Product Description 54
Flint Rehabilitation Pipeline Products & Ongoing Clinical Trials Overview 55
FitMi VNS System – Product Status 55
FitMi VNS System – Product Description 55
FRD Accel LLC Pipeline Products & Ongoing Clinical Trials Overview 56
BabyStrong TaVNS Bottle Feeding System – Product Status 56
BabyStrong TaVNS Bottle Feeding System – Product Description 56
LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 57
Aspire NP – Product Status 57
Aspire NP – Product Description 58
Centro Generator – Product Status 58
Centro Generator – Product Description 58
CentroSR Generator – Product Status 59
CentroSR Generator – Product Description 59
EpiTrace – Product Status 59
EpiTrace – Product Description 59
Equilia – Product Status 60
Equilia – Product Description 60
Griffin – Pulse Generator – Product Status 60
Griffin – Pulse Generator – Product Description 61
Intense Neuromodulation System – Heart Failure – Product Status 61
Intense Neuromodulation System – Heart Failure – Product Description 61
Microburst VNS Stimulator – Product Status 61
Microburst VNS Stimulator – Product Description 62
PhoenixRF SR – Product Status 62
PhoenixRF SR – Product Description 62
VITARIA System – Chronic Heart Failure – Product Status 63
VITARIA System – Chronic Heart Failure – Product Description 63
WaveLink – Product Status 63
WaveLink – Product Description 64
LivaNova PLC – Ongoing Clinical Trials Overview 65
VITARIA System – Chronic Heart Failure – Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure with Reduced Ejection Fraction 66
Medical University of South Carolina Pipeline Products & Ongoing Clinical Trials Overview 67
BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) – Product Status 67
BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) – Product Description 67
Medical University of South Carolina – Ongoing Clinical Trials Overview 68
BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) – BabyStrong taVNS-Paired Bottle Feeding to Improve Oral Feeding 69
MicroTransponder Inc Pipeline Products & Ongoing Clinical Trials Overview 70
SAINT System – Anxiety Disorders – Product Status 70
SAINT System – Anxiety Disorders – Product Description 70
SAINT System – Tinnitus – Product Status 71
SAINT System – Tinnitus – Product Description 71
Serenity System – Product Status 71
Serenity System – Product Description 72
Nemechek Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 73
Vitality Smartcable – COVID-19 – Product Status 73
Vitality Smartcable – COVID-19 – Product Description 73
Nexeon MedSystems Inc Pipeline Products & Ongoing Clinical Trials Overview 74
Auricular Vagus Nerve Stimulator – Asthma – Product Status 74
Auricular Vagus Nerve Stimulator – Asthma – Product Description 74
aVNS Device – Product Status 75
aVNS Device – Product Description 75
Vagus Nerve Stimulator – Asthma – Product Status 75
Vagus Nerve Stimulator – Asthma – Product Description 76
Otto Bock HealthCare GmbH Pipeline Products & Ongoing Clinical Trials Overview 77
Neuromodulation Device – Epilepsy – Product Status 77
Neuromodulation Device – Epilepsy – Product Description 77
Neuromodulation Device – Sleep Apnea – Product Status 78
Neuromodulation Device – Sleep Apnea – Product Description 78
Parasym Ltd Pipeline Products & Ongoing Clinical Trials Overview 79
Parasym Device – Product Status 79
Parasym Device – Product Description 79
Parasym Ltd – Ongoing Clinical Trials Overview 80
Parasym Device – Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A) 81
Parasym Device – Multimodal Investigation of Post COVID-19 in Females: A Pilot Study 81
Parasym Device – Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis 81
Parasym Device – Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes (NoVa-PVC) 82
Parasym Device – The Effect of Different Low-level Tragus Stimulation Parameters on Autonomic Nervous System Function 82
Parasym Device – Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction: A Randomized Clinical Trial 82
Pulsetto UAB Pipeline Products & Ongoing Clinical Trials Overview 83
Vagus Nerve Stimulator – Product Status 83
Vagus Nerve Stimulator – Product Description 83
Pulsus Medical LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 84
VNS Device – Product Status 84
VNS Device – Product Description 84
Purdue University Pipeline Products & Ongoing Clinical Trials Overview 85
Bionode Device – Product Status 85
Bionode Device – Product Description 85
ReShape Lifesciences Inc Pipeline Products & Ongoing Clinical Trials Overview 86
Diabetes Bloc-Stim Neuromodulation Device – Product Status 86
Diabetes Bloc-Stim Neuromodulation Device – Product Description 86
Diabetes Bloc-Stim Neuromodulation Device – Hypoglycemia – Product Status 87
Diabetes Bloc-Stim Neuromodulation Device – Hypoglycemia – Product Description 87
Soterix Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 88
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Device – Product Status 88
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Device – Product Description 88
Soterix Medical Inc – Ongoing Clinical Trials Overview 89
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 90
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Device – Extending taVNS Paired With Infant CIMT Into a Home-Based Setting: Technology Development Requisite for a Randomized Trial 90
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Device – Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Persistent Symptoms from Lyme Disease: A Feasibility, Tolerability, and Safety Study 90
SUNY Downstate Medical Center Pipeline Products & Ongoing Clinical Trials Overview 91
Vagus Nerve Stimulator – Ventricular Arrhythmia – Product Status 91
Vagus Nerve Stimulator – Ventricular Arrhythmia – Product Description 91
Synergia Medical SA Pipeline Products & Ongoing Clinical Trials Overview 92
NAO·VNS – Chronic Pain – Product Status 92
NAO·VNS – Chronic Pain – Product Description 92
NAO·VNS – Depression – Product Status 93
NAO·VNS – Depression – Product Description 93
NAO·VNS – Epilepsy – Product Status 93
NAO·VNS – Epilepsy – Product Description 94
NAO·VNS – Parkinson’s Disease – Product Status 94
NAO·VNS – Parkinson’s Disease – Product Description 94
NAO·VNS – Sleep Apnoea – Product Status 95
NAO·VNS – Sleep Apnoea – Product Description 95
Texas Biomedical Device Center Pipeline Products & Ongoing Clinical Trials Overview 96
ReStore Wireless Vagus Nerve Stimulator – Product Status 96
ReStore Wireless Vagus Nerve Stimulator – Product Description 96
Texas Biomedical Device Center – Ongoing Clinical Trials Overview 97
ReStore Wireless Vagus Nerve Stimulator – Wireless Nerve Stimulation Device to Enhance Recovery after Stroke 98
The Feinstein Institute for Medical Research Pipeline Products & Ongoing Clinical Trials Overview 99
Bioelectronic Medicine Device – Heart Failure – Product Status 99
Bioelectronic Medicine Device – Heart Failure – Product Description 99
Bioelectronic Medicine Device – Lupus – Product Status 100
Bioelectronic Medicine Device – Lupus – Product Description 100
Bioelectronic Medicine Device – Obesity – Product Status 100
Bioelectronic Medicine Device – Obesity – Product Description 101
Bioelectronic Medicine Device – Pulmonary Hypertension – Product Status 101
Bioelectronic Medicine Device – Pulmonary Hypertension – Product Description 101
Neurochip – Product Status 102
Neurochip – Product Description 102
Trifectas Medical Corp. Pipeline Products & Ongoing Clinical Trials Overview 103
Neurostimulation Device – Stroke Recovery – Product Status 103
Neurostimulation Device – Stroke Recovery – Product Description 103
University of Alabama Pipeline Products & Ongoing Clinical Trials Overview 104
VNS Device – Depression – Product Status 104
VNS Device – Depression – Product Description 104
University of Auckland Pipeline Products & Ongoing Clinical Trials Overview 105
Electroceutical Device – Product Status 105
Electroceutical Device – Product Description 105
University of Pittsburgh Pipeline Products & Ongoing Clinical Trials Overview 106
Closed-Loop Neuroelectric Device – Product Status 106
Closed-Loop Neuroelectric Device – Product Description 106
University of Wisconsin Madison Pipeline Products & Ongoing Clinical Trials Overview 107
Implantable Weight-Loss Device – Product Status 107
Implantable Weight-Loss Device – Product Description 107
VA Pittsburgh Healthcare System Pipeline Products & Ongoing Clinical Trials Overview 108
Auricular Vagus Nerve Stimulation Device – Product Status 108
Auricular Vagus Nerve Stimulation Device – Product Description 108
Glossary 118