Spinal Cord Stimulators (SCS) – Pipeline Products by Stage of Development 12
Spinal Cord Stimulators (SCS) – Pipeline Products by Territory 13
Spinal Cord Stimulators (SCS) – Pipeline Products by Regulatory Path 14
Spinal Cord Stimulators (SCS) – Pipeline Products by Estimated Approval Date 15
Spinal Cord Stimulators (SCS) – Ongoing Clinical Trials 16
Spinal Cord Stimulators (SCS) Companies – Pipeline Products by Stage of Development 17
Spinal Cord Stimulators (SCS) – Pipeline Products by Stage of Development 19
Beijing Lingchuang Yigu Technology Development Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 21
Neural Electrical Stimulation Device – Pain – Product Status 21
Neural Electrical Stimulation Device – Pain – Product Description 21
Biotronik Inc Pipeline Products & Ongoing Clinical Trials Overview 22
Prospera SCS System – Product Status 22
Prospera SCS System – Product Description 22
Biotronik Inc – Ongoing Clinical Trials Overview 23
Prospera SCS System – BENEFIT-03 Clinical Study 24
Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 25
Next Generation SCS System – Product Status 25
Next Generation SCS System – Product Description 25
Cerevast Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 26
Transdermal Electrical Neurostimulation Device – Product Status 26
Transdermal Electrical Neurostimulation Device – Product Description 26
Direct Spinal Therapeutics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 27
Iowa-Patch System – Product Status 27
Iowa-Patch System – Product Description 27
Duke University Pipeline Products & Ongoing Clinical Trials Overview 28
Spinal Cord Stimulator – Product Status 28
Spinal Cord Stimulator – Product Description 28
GTX Medical BV Pipeline Products & Ongoing Clinical Trials Overview 29
Go-2 Targeted Epidural Spinal Stimulation Device – Product Status 29
Go-2 Targeted Epidural Spinal Stimulation Device – Product Description 29
GTX Medical BV – Ongoing Clinical Trials Overview 30
Go-2 Targeted Epidural Spinal Stimulation Device – Efficacy of Spinal Epidural Electrical Stimulation (EES) in Combination with Robot-assisted Neurorehabilitation in Patients with Spinal Cord Injury (STIMO) 31
Go-2 Targeted Epidural Spinal Stimulation Device – Targeting Improvements in Bowel Function and Quality of Life Using Epidural Stimulation and Training After Severe Spinal Cord Injury 31
Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 32
Wireless Intraspinal Microstimulation System – Product Status 32
Wireless Intraspinal Microstimulation System – Product Description 32
Lawson Health Research Institute Pipeline Products & Ongoing Clinical Trials Overview 33
Spinal Implant – Parkinson’s Disease – Product Status 33
Spinal Implant – Parkinson’s Disease – Product Description 33
Meagan Medical Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
DISCSS IFC System – Product Status 34
DISCSS IFC System – Product Description 34
Medtronic Inc Pipeline Products & Ongoing Clinical Trials Overview 35
Inceptiv SCS – Product Status 35
Inceptiv SCS – Product Description 35
Medtronic Inc – Ongoing Clinical Trials Overview 36
Inceptiv SCS – Evaluation of Long-term Patient Experience with a Medtronic Closed-Loop Spinal Cord Stimulation System 37
Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 38
Intellis – Non-Surgical Refractory Back Pain – Product Status 38
Intellis – Non-Surgical Refractory Back Pain – Product Description 39
Intellis – Painful Diabetic Neuropathy – Product Status 39
Intellis – Painful Diabetic Neuropathy – Product Description 39
Intellis – Upper Limb And Neck – Product Status 40
Intellis – Upper Limb And Neck – Product Description 40
Next Generation Intellis – Rechargeable – Product Status 40
Next Generation Intellis – Rechargeable – Product Description 41
PrimeADVANCED – Heart Failure – Product Status 41
PrimeADVANCED – Heart Failure – Product Description 41
Micro-Leads Inc Pipeline Products & Ongoing Clinical Trials Overview 42
HD64 Implantable Therapy System – Product Status 42
HD64 Implantable Therapy System – Product Description 42
Intelligent Spinal Interface – Product Status 43
Intelligent Spinal Interface – Product Description 43
STIM-GRID MAP Spinal Cord Paddle – Product Status 43
STIM-GRID MAP Spinal Cord Paddle – Product Description 44
MicroTransponder Inc Pipeline Products & Ongoing Clinical Trials Overview 45
SAINT System – Chronic Pain – Product Status 45
SAINT System – Chronic Pain – Product Description 45
Neuronoff Inc Pipeline Products & Ongoing Clinical Trials Overview 46
Injectrode – Product Status 46
Injectrode – Product Description 46
Neuronoff Inc – Ongoing Clinical Trials Overview 47
Injectrode – Basic Assessment of Safety and Minimally Invasive Stimulation via Injectrode 48
NeuroOne Medical Technologies Corp Pipeline Products & Ongoing Clinical Trials Overview 49
Spinal Cord Stimulation System – Chronic Back Pain – Product Status 49
Spinal Cord Stimulation System – Chronic Back Pain – Product Description 49
Nevro Corp Pipeline Products & Ongoing Clinical Trials Overview 50
Omnia Upgrade – Product Status 51
Omnia Upgrade – Product Description 51
Senza HF10 Therapy System – Back Pain – Product Status 51
Senza HF10 Therapy System – Back Pain – Product Description 52
Senza HF10 Therapy System – Chronic Abdominal Pain – Product Status 52
Senza HF10 Therapy System – Chronic Abdominal Pain – Product Description 52
Senza HF10 Therapy System – Chronic Migraine – Product Status 53
Senza HF10 Therapy System – Chronic Migraine – Product Description 53
Senza HF10 Therapy System – Chronic Neck Pain – Product Status 53
Senza HF10 Therapy System – Chronic Neck Pain – Product Description 54
Senza HF10 Therapy System – CPSP – Product Status 54
Senza HF10 Therapy System – CPSP – Product Description 54
Senza HF10 Therapy System – Leg Pain – Product Status 55
Senza HF10 Therapy System – Leg Pain – Product Description 55
Senza HF10 Therapy System – Non-Surgical Refractory Back Pain – Product Status 55
Senza HF10 Therapy System – Non-Surgical Refractory Back Pain – Product Description 56
Senza HF10 Therapy System – Opioid Reduction – Product Status 56
Senza HF10 Therapy System – Opioid Reduction – Product Description 57
Senza HF10 Therapy System – Painful Diabetic Neuropathy – Product Status 57
Senza HF10 Therapy System – Painful Diabetic Neuropathy – Product Description 57
Senza HF10 Therapy System – Pelvic Pain – Product Status 58
Senza HF10 Therapy System – Pelvic Pain – Product Description 58
Senza HF10 Therapy System – Peripheral Polyneuropathy – Product Status 58
Senza HF10 Therapy System – Peripheral Polyneuropathy – Product Description 59
Senza HF10 Therapy System – Post-Surgical Pain – Product Status 59
Senza HF10 Therapy System – Post-Surgical Pain – Product Description 59
Senza HF10 Therapy System – Rescue Therapy – Product Status 60
Senza HF10 Therapy System – Rescue Therapy – Product Description 60
Senza HF10 Therapy System – Thoracic Pain – Product Status 60
Senza HF10 Therapy System – Thoracic Pain – Product Description 61
Senza HF10 Therapy System – Upper Extremity Pain – Product Status 61
Senza HF10 Therapy System – Upper Extremity Pain – Product Description 61
Senza HF10 Therapy System – Upper Limb Pain – Product Status 62
Senza HF10 Therapy System – Upper Limb Pain – Product Description 62
Nevro Corp – Ongoing Clinical Trials Overview 63
Senza HF10 Therapy System – Post-Surgical Pain – A Prospective, Post-market Study to Investigate the Effect of HF10 Therapy for the Treatment of Chronic Post-Surgical Shoulder Pain 64
Senza HF10 Therapy System – Painful Diabetic Neuropathy – A Post-market, Multicenter, Prospective, Global Clinical Study to Evaluate the Real-world Experience of Spinal Cord Stimulation That Includes 10 kHz in the Management of Chronic Intractable Pain Associated with Diabetic Neuropathy 65
Senza HF10 Therapy System – Painful Diabetic Neuropathy – A Post-market, Multicenter, Prospective, Randomized Clinical Trial Comparing 10 kHz Spinal Cord Stimulation (HF10 Therapy) Combined with Conventional Medical Management to Conventional Medical Management Alone in the Treatment of Chronic, Intractable, Neuropathic Limb Pain 65
Senza HF10 Therapy System – Back Pain – A Multi-center, Prospective, Pragmatic, Randomized, Controlled Clinical Trial to Compare HF10 Therapy to Conventional Medical Management in the Treatment of Non-surgical Refractory Back Pain 66
Senza HF10 Therapy System – Leg Pain – A Multi-center Prospective Observational Clinical Study to Evaluate HF10 Therapy in Patients with Chronic Intractable Predominant Leg Pain 67
Senza HF10 Therapy System – Leg Pain – A Prospective Post-market Study to Investigate the Effect of HF10 Therapy on Opioid Analgesic Use for the Treatment of Chronic Intractable Low Back and/or Radicular Leg Pain 67
Nexstim Plc Pipeline Products & Ongoing Clinical Trials Overview 68
Navigated Brain Therapy System – Chronic Spinal Cord Injury – Product Status 68
Navigated Brain Therapy System – Chronic Spinal Cord Injury – Product Description 68
Nuvectra Corp Pipeline Products & Ongoing Clinical Trials Overview 69
Algovita SCS System – Full Body MRI – Product Status 69
Algovita SCS System – Full Body MRI – Product Description 69
Onward Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 70
ARC-EX – Product Status 70
ARC-EX – Product Description 71
ARC-IM – Blood Pressure And Trunk Control – Product Status 71
ARC-IM – Blood Pressure And Trunk Control – Product Description 71
ARCEX Neurostimulator – Product Status 72
ARCEX Neurostimulator – Product Description 72
Onward Technologies Ltd – Ongoing Clinical Trials Overview 73
ARC-EX – Activity Dependent Rehabilitation Via Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury 74
ARC-EX – Clinical Assessment of Upper Extremity Performance in Individuals with Spinal Cord Injury Using the LIFT System to Deliver Non-invasive Electrical Spinal Stimulation (ARC Therapy) 74
ARC-EX – Safety and Performance Assessment of the LIFT System When Used to Support Home-based Upper Extremity Training in Individuals with Spinal Cord Injury 74
ARC-IM – Blood Pressure And Trunk Control – Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People with Spinal Cord Injury 75
Quantum Nanostim LLC Pipeline Products & Ongoing Clinical Trials Overview 76
Clone System – Product Status 76
Clone System – Product Description 76
Saluda Medical Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 77
Evoke Spinal Cord Stimulator System – Product Status 77
Evoke Spinal Cord Stimulator System – Product Description 77
Saluda Medical Pty Ltd – Ongoing Clinical Trials Overview 78
Evoke Spinal Cord Stimulator System – A Feasibility Study Evaluating Saluda Medical’s Spinal Cord Stimulation System Incorporating Feedback Control to Treat Patients with Chronic Pain of Upper Limb and/or Neck 79
Evoke Spinal Cord Stimulator System – A Prospective Study to Evaluate the Long-term Effectiveness, Safety, and Performance of the Saluda Medical’s Evoke Closed-Loop Spinal Cord Stimulation System to Treat Patients with Chronic Pain of the Trunk and/or Limbs 79
Evoke Spinal Cord Stimulator System – A Prospective, Multicenter, Randomized Double-blind Study Examining the Safety and Efficacy of Using the Evoke Spinal Cord Stimulator (SCS) System with Feedback to Treat Patients with Chronic Pain of the Trunk and/or Limbs 79
Evoke Spinal Cord Stimulator System – A Prospective, Multicentre, Single-arm Feasibility Study Examining Novel Treatment Delivery of the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients with Chronic Pain of the Trunk And/or Limbs 80
Evoke Spinal Cord Stimulator System – Prospective Data Collection to Evaluate the Feedback Control of the Saluda Medical’s Evoke Spinal Cord Stimulation System in the Treatment of Patients With Chronic Pain of the Trunk and/or Limbs 80
Soin Neuroscience Inc Pipeline Products & Ongoing Clinical Trials Overview 81
Spinal Cord Stimulation System – Product Status 81
Spinal Cord Stimulation System – Product Description 81
Soterix Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 82
1×1 tDCS Device – Product Status 82
1×1 tDCS Device – Product Description 83
tSDCS Cervical Strap – Product Status 83
tSDCS Cervical Strap – Product Description 83
tSDCS Lumbar BODYstrap – Product Status 84
tSDCS Lumbar BODYstrap – Product Description 84
tSDCS Shoulder Strap – Product Status 84
tSDCS Shoulder Strap – Product Description 85
Soterix Medical Inc – Ongoing Clinical Trials Overview 86
1×1 tDCS Device – Altering Multitasking Behavior Using Low Current Brain Stimulation 87
1×1 tDCS Device – Effects of Transcranial Direct Current Stimulation (tDCS) in Spoken and Written Production in Primary Progressive Aphasia (PPA) 87
1×1 tDCS Device – Effects of Transcranial Direct Current Stimulation (tDCS) on Motor Function in Schizophrenia Patients and Individuals at Risk for Psychotic Onset 87
1×1 tDCS Device – Impact of Neuromodulation on Language Impairments in Stroke Patients: A Multimodal Double-blind Randomized Controlled Study 88
1×1 tDCS Device – Non-invasive Neuromodulation to Enhance Targeted Cognitive Remediation in Older Adults With Depression 88
1×1 tDCS Device – Phase II Clinical Trial of Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia 88
1×1 tDCS Device – The Combined Effect of Robotic Rehabilitation and Transcranial Direct Current Stimulation on Proprioception in Chronic Stroke: a Pilot Study 89
SpineX Pipeline Products & Ongoing Clinical Trials Overview 90
SCiP – Product Status 90
SCiP – Product Description 90
Scone Device – Product Status 91
Scone Device – Product Description 91
SpineX – Ongoing Clinical Trials Overview 92
Scone Device – Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals with Cerebral Palsy 93
Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 94
Spinal Cord Stimulator – Chronic Pain – Product Status 94
Spinal Cord Stimulator – Chronic Pain – Product Description 94
St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 95
Next Generation Implantable SCS System – Primary Cell – Product Status 95
Next Generation Implantable SCS System – Primary Cell – Product Description 95
Next Generation Implantable SCS System – Rechargeable – Product Status 96
Next Generation Implantable SCS System – Rechargeable – Product Description 96
Proclaim Rechargeable Model – Product Status 96
Proclaim Rechargeable Model – Product Description 96
Proclaim Upgrade HC – Product Status 97
Proclaim Upgrade HC – Product Description 97
Proclaim Upgrade LC – Product Status 97
Proclaim Upgrade LC – Product Description 98
Proclaim XR – Product Status 98
Proclaim XR – Product Description 98
St. Jude Medical LLC – Ongoing Clinical Trials Overview 99
Proclaim XR – Effects of Active Versus Passive Recharge Burst Spinal Cord Stimulation on Pain Experience in Persistent Spinal Pain Syndrome Type 2: A Multicenter Randomized Trial (BURST-RAP Study) 100
Stimdia Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 101
pdSTIM System – Product Status 101
pdSTIM System – Product Description 101
SynerFuse Inc Pipeline Products & Ongoing Clinical Trials Overview 102
NeuroFuse DRG System – Product Status 102
NeuroFuse DRG System – Product Description 102
SynerFuse Inc – Ongoing Clinical Trials Overview 103
NeuroFuse DRG System – Pilot Trial to Investigate NeuroFuse DRG Therapy in Patients with Chronic Lower Back Pain 104
Teliatry Inc Pipeline Products & Ongoing Clinical Trials Overview 105
16 Channel Spinal Cord Stimulator – Product Status 105
16 Channel Spinal Cord Stimulator – Product Description 105
University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 106
32-Electrode Neurostimulator – Product Status 106
32-Electrode Neurostimulator – Product Description 106
Spinal Cord Electrical Stimulator – Product Status 107
Spinal Cord Electrical Stimulator – Product Description 107
University of Cambridge Pipeline Products & Ongoing Clinical Trials Overview 108
Inflatable Spinal Implant – Product Status 108
Inflatable Spinal Implant – Product Description 108
University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 109
Spinal Cord Stimulation Device – Product Status 109
Spinal Cord Stimulation Device – Product Description 109
University of Minnesota – Ongoing Clinical Trials Overview 110
Spinal Cord Stimulation Device – Epidural Stimulation for Spinal Cord Injury 111
Wavegate Corp Pipeline Products & Ongoing Clinical Trials Overview 112
StimuLux – Product Status 112
StimuLux – Product Description 112
WISE s.r.l. Pipeline Products & Ongoing Clinical Trials Overview 113
SCS EXPERT – Product Status 113
SCS EXPERT – Product Description 113
Glossary 128
