Vagus Nerve Stimulators - Medical Devices Pipeline Assessment, 2017

Published : Aug-2017

No. of Pages : 97

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Table of Contents
1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 5
2 Introduction 6
2.1 Vagus Nerve Stimulators Overview 6
3 Products under Development 7
3.1 Vagus Nerve Stimulators - Pipeline Products by Stage of Development 7
3.2 Vagus Nerve Stimulators - Pipeline Products by Territory 8
3.3 Vagus Nerve Stimulators - Pipeline Products by Regulatory Path 9
3.4 Vagus Nerve Stimulators - Pipeline Products by Estimated Approval Date 10
3.5 Vagus Nerve Stimulators - Ongoing Clinical Trials 11
4 Vagus Nerve Stimulators - Pipeline Products under Development by Companies 12
4.1 Vagus Nerve Stimulators Companies - Pipeline Products by Stage of Development 12
4.2 Vagus Nerve Stimulators - Pipeline Products by Stage of Development 13
5 Vagus Nerve Stimulators Companies and Product Overview 14
5.1 BioControl Medical Company Overview 14
5.1.1 BioControl Medical Pipeline Products & Ongoing Clinical Trials Overview 14
5.2 Boston Scientific Corp Company Overview 15
5.2.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 15
5.3 CerboMed GmbH Company Overview 19
5.3.1 CerboMed GmbH Pipeline Products & Ongoing Clinical Trials Overview 19
5.4 Cerebral RX Ltd. Company Overview 20
5.4.1 Cerebral RX Ltd. Pipeline Products & Ongoing Clinical Trials Overview 20
5.5 Cyberonics Inc Company Overview 21
5.5.1 Cyberonics Inc Pipeline Products & Ongoing Clinical Trials Overview 21
5.6 DuoCure Ltd. Company Overview 22
5.6.1 DuoCure Ltd. Pipeline Products & Ongoing Clinical Trials Overview 22
5.7 ElectroCore, LLC Company Overview 23
5.7.1 ElectroCore, LLC Pipeline Products & Ongoing Clinical Trials Overview 23
5.8 LivaNova PLC Company Overview 28
5.8.1 LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 28
5.9 Medical University of South Carolina Company Overview 36
5.9.1 Medical University of South Carolina Pipeline Products & Ongoing Clinical Trials Overview 36
5.10 MicroTransponder Inc Company Overview 37
5.10.1 MicroTransponder Inc Pipeline Products & Ongoing Clinical Trials Overview 37
5.11 Otto Bock HealthCare GmbH Company Overview 43
5.11.1 Otto Bock HealthCare GmbH Pipeline Products & Ongoing Clinical Trials Overview 43
5.12 Purdue University Company Overview 45
5.12.1 Purdue University Pipeline Products & Ongoing Clinical Trials Overview 45
5.13 Setpoint Medical Corp Company Overview 46
5.13.1 Setpoint Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 46
5.14 Trifectas Medical Corp. Company Overview 50
5.14.1 Trifectas Medical Corp. Pipeline Products & Ongoing Clinical Trials Overview 50
6 Vagus Nerve Stimulators- Recent Developments 51
6.1 Aug 01, 2017: VNS Therapy Receives CE Mark for Expanded MRI Labeling 51
6.2 Jul 31, 2017: SetPoint Medical Appoints Terry Bevirt as VP of Clinical Affairs 51
6.3 Jul 27, 2017: Boston Scientific Announces Results for Second Quarter 2017 52
6.4 Jul 18, 2017: GammaCore, The First Non-Invasive Vagus Nerve Stimulator Applied At The Neck, Now Available For Adult Patients In The U.S. 54
6.5 Jun 29, 2017: FDA Approves VNS Therapy Treatment for Drug-Resistant Epilepsy in Children as Young as Four Years Old 54
6.6 Jun 27, 2017: Boston Scientific Outlines Strategy for Sustained Growth at 2017 Investor Day 56
6.7 Jun 21, 2017: VNS Therapy Receives FDA Approval for Expanded MRI Labeling 58
6.8 Jun 15, 2017: SetPoint Medical Appoints David Chernoff, MD as Chief Medical Officer 58
6.9 Jun 12, 2017: LivaNova Appoints Keyna Skeffington as Senior Vice President and General Counsel 59
6.10 Jun 08, 2017: New Analysis of ACT Clinical Trial Program Highlights Efficacy and Safety of electroCore's gammaCore (non-invasive vagus nerve stimulator) in the Acute Treatment of Episodic Cluster Headache 60
6.11 May 30, 2017: MicroTransponder Presents Long Term Stroke Trial Data at INS and Announces a 120 Patient Pivotal Stroke Trial 61
6.12 May 16, 2017: LivaNova Announces Thad Huston as Chief Financial Officer 61
6.13 May 03, 2017: LivaNova Reports First Quarter 2017 Results 62
6.14 Apr 27, 2017: Boston Scientific Announces Results For First Quarter 2017 63
6.15 Apr 26, 2017: electroCore Announces Data Presentation at the 69th American Academy of Neurology Annual Meeting 64
6.16 Apr 18, 2017: FDA Releases gammaCore, the First Non-Invasive Vagus Nerve Stimulation Therapy Applied at the Neck for Acute Treatment of Pain Associated with Episodic Cluster Headache in Adult Patients 65
6.17 Mar 31, 2017: New Study Finds Promising Treatment Option for Treatment-Resistant Depression 66
6.18 Mar 31, 2017: LivaNova Announces Chief Financial Officer Resignation 67
6.19 Mar 31, 2017: LivaNova Reiterates Full-Year 2017 Guidance 67
6.20 Mar 01, 2017: LivaNova Reports Fourth Quarter and Full-Year 2016 Results 67
6.21 Feb 28, 2017: Results for the second quarter of Fiscal year 2017 - Ergoresearch reports its results for the quarter ended December 31, 2016 70
6.22 Feb 23, 2017: LivaNova Announces Its Intent to Delist from London Stock Exchange 71
6.23 Feb 02, 2017: Boston Scientific Announces Results For Fourth Quarter And Full Year Ended December 31, 2016 71
6.24 Jan 04, 2017: SetPoint Medical Presents Positive Results In Ongoing Crohn's Disease Study 73
6.25 Nov 28, 2016: Results for the first quarter of Fiscal year 2017 - Ergoresearch reports its results for the quarter ended 73
6.26 Nov 28, 2016: Ergoresearch reports its results for the quarter ended September 30, 2016 74
6.27 Nov 14, 2016: Mount Sinai Beth Israel Receive Award from The United States Department of Defense to Study Gulf War Illness with electroCore's non-invasive vagus nerve stimulation therapy 75
6.28 Nov 10, 2016: VNS Therapy is Proven Treatment Option, but Treatment Gap Remains 76
6.29 Nov 02, 2016: LivaNova Announces CEO Transition: Damien McDonald to Succeed Andre-Michel Ballester 77
6.30 Nov 02, 2016: LivaNova Reports Third Quarter 2016 Results 77
6.31 Oct 28, 2016: Results for the fourth quarter and the fiscal year ended June 30, 2016 - Ergoresearch reports its 2016 annual results 79
6.32 Oct 26, 2016: Boston Scientific Announces Results For Third Quarter 2016 79
6.33 Oct 19, 2016: SetPoint Medical Presents Positive Clinical Results in Crohn's Disease 81
6.34 Oct 19, 2016: St. Jude Medical Reports Third Quarter 2016 Results 82
6.35 Oct 10, 2016: Professor Ian Meredith To Join Boston Scientific As Executive Vice President And Global Chief Medical Officer 83
6.36 Sep 29, 2016: LivaNova Announces Half-Year Financial Report 84
7 Appendix 94
7.1 Methodology 94
7.2 About GlobalData 97
7.3 Contact Us 97
7.4 Disclaimer 97

1.1 List of Tables
Table 1: Vagus Nerve Stimulators - Pipeline Products by Stage of Development 7
Table 2: Vagus Nerve Stimulators - Pipeline Products by Territory 8
Table 3: Vagus Nerve Stimulators - Pipeline Products by Regulatory Path 9
Table 4: Vagus Nerve Stimulators - Pipeline Products by Estimated Approval Date 10
Table 5: Vagus Nerve Stimulators - Ongoing Clinical Trials 11
Table 6: Vagus Nerve Stimulators Companies - Pipeline Products by Stage of Development 12
Table 7: Vagus Nerve Stimulators - Pipeline Products by Stage of Development 13
Table 8: BioControl Medical Pipeline Products & Ongoing Clinical Trials Overview 14
Table 9: CardioFit System - Product Status 14
Table 10: CardioFit System - Product Description 14
Table 11: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 15
Table 12: AMT System - Product Status 15
Table 13: AMT System - Product Description 15
Table 14: Vagal Nerve Stimulator - Product Status 16
Table 15: Vagal Nerve Stimulator - Product Description 16
Table 16: Boston Scientific Corp - Ongoing Clinical Trials Overview 17
Table 17: Vagal Nerve Stimulator - Neural Cardiac Therapy for Heart Failure Study 18
Table 18: CerboMed GmbH Pipeline Products & Ongoing Clinical Trials Overview 19
Table 19: t-VNS - Dementia - Product Status 19
Table 20: t-VNS - Dementia - Product Description 19
Table 21: Cerebral RX Ltd. Pipeline Products & Ongoing Clinical Trials Overview 20
Table 22: FitNes System - Alzheimer's Disease - Product Status 20
Table 23: FitNes System - Alzheimer's Disease - Product Description 20
Table 24: Cyberonics Inc Pipeline Products & Ongoing Clinical Trials Overview 21
Table 25: Nerve Wrap - Product Status 21
Table 26: Nerve Wrap - Product Description 21
Table 27: DuoCure Ltd. Pipeline Products & Ongoing Clinical Trials Overview 22
Table 28: Intraluminal Implantable Device - Product Status 22
Table 29: Intraluminal Implantable Device - Product Description 22
Table 30: ElectroCore, LLC Pipeline Products & Ongoing Clinical Trials Overview 23
Table 31: GammaCore - Medication Overuse Headache - Product Status 23
Table 32: GammaCore - Medication Overuse Headache - Product Description 23
Table 33: GammaCore - Migraine - Product Status 24
Table 34: GammaCore - Migraine - Product Description 24
Table 35: Resolve Stimulator - Product Status 24
Table 36: Resolve Stimulator - Product Description 25
Table 37: ElectroCore, LLC - Ongoing Clinical Trials Overview 26
Table 38: GammaCore - Migraine - A Prospective, Multi-centre, Randomized, Double-blind, Sham-controlled Study of gammaCore Non-invasive Vagus Nerve Stimulator (nVNS) for the Acute Treatment of Migraine 27
Table 39: LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 28
Table 40: Aspire NP - Product Status 28
Table 41: Aspire NP - Product Description 29
Table 42: Centro Generator - Product Status 29
Table 43: Centro Generator - Product Description 29
Table 44: CentroSR Generator - Product Status 30
Table 45: CentroSR Generator - Product Description 30
Table 46: Equilia - Product Status 30
Table 47: Equilia - Product Description 31
Table 48: Griffin - Pulse Generator - Product Status 31
Table 49: Griffin - Pulse Generator - Product Description 31
Table 50: Intense Neuromodulation - Heart Failure - Product Status 32
Table 51: Intense Neuromodulation - Heart Failure - Product Description 32
Table 52: PhoenixRF SR - Product Status 32
Table 53: PhoenixRF SR - Product Description 33
Table 54: VITARIA System - Chronic Heart Failure - Product Status 33
Table 55: VITARIA System - Chronic Heart Failure - Product Description 33
Table 56: LivaNova PLC - Ongoing Clinical Trials Overview 34
Table 57: Equilia - Vagal Nerve Stimulation: Safe-guarding Heart Failure Patients (VANGUARD) 35
Table 58: Medical University of South Carolina Pipeline Products & Ongoing Clinical Trials Overview 36
Table 59: Transcutaneous Auricular Vagus Nerve Stimulator (taVNS) - Product Status 36
Table 60: Transcutaneous Auricular Vagus Nerve Stimulator (taVNS) - Product Description 36
Table 61: MicroTransponder Inc Pipeline Products & Ongoing Clinical Trials Overview 37
Table 62: SAINT System - Anxiety Disorders - Product Status 37
Table 63: SAINT System - Anxiety Disorders - Product Description 38
Table 64: SAINT System - Tinnitus - Product Status 38
Table 65: SAINT System - Tinnitus - Product Description 38
Table 66: Serenity System - Tinnitus - Product Status 39
Table 67: Serenity System - Tinnitus - Product Description 39
Table 68: Vivistim Device - Product Status 39
Table 69: Vivistim Device - Product Description 40
Table 70: MicroTransponder Inc - Ongoing Clinical Trials Overview 41
Table 71: Vivistim Device - A Pivotal Randomized Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function after Stroke: VNS-REHAB 42
Table 72: Vivistim Device - A Randomized Pilot Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function after Stroke (MicroTransponder's Vivistim System) - Study MT-St-02 - Stroke 42
Table 73: Otto Bock HealthCare GmbH Pipeline Products & Ongoing Clinical Trials Overview 43
Table 74: Neuromodulation Device - Epilepsy - Product Status 43
Table 75: Neuromodulation Device - Epilepsy - Product Description 43
Table 76: Neuromodulation Device - Sleep Apnea - Product Status 44
Table 77: Neuromodulation Device - Sleep Apnea - Product Description 44
Table 78: Purdue University Pipeline Products & Ongoing Clinical Trials Overview 45
Table 79: Bionode Device - Product Status 45
Table 80: Bionode Device - Product Description 45
Table 81: Setpoint Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 46
Table 82: Implantable Neurostimulation Device - Rheumatoid Arthritis - Product Status 46
Table 83: Implantable Neurostimulation Device - Rheumatoid Arthritis - Product Description 46
Table 84: SetPoint Immune System Regulator - Crohn's Disease - Product Status 47
Table 85: SetPoint Immune System Regulator - Crohn's Disease - Product Description 47
Table 86: Setpoint Medical Corp - Ongoing Clinical Trials Overview 48
Table 87: SetPoint Immune System Regulator - Crohn's Disease - Study of the Safety and Efficacy of Neurostimulation of the Cholinergic Anti-inflammatory Pathway Using a Vagal Nerve Stimulation Device in Patients with Active Refractory Crohn's Disease 49
Table 88: Trifectas Medical Corp. Pipeline Products & Ongoing Clinical Trials Overview 50
Table 89: Neurostimulation Device - Stroke Recovery - Product Status 50
Table 90: Neurostimulation Device - Stroke Recovery - Product Description 50
Table 91: Glossary 96

1.2 List of Figures
Figure 1: Vagus Nerve Stimulators - Pipeline Products by Stage of Development 7
Figure 2: Vagus Nerve Stimulators - Pipeline Products by Territory 8
Figure 3: Vagus Nerve Stimulators - Pipeline Products by Regulatory Path 9
Figure 4: Vagus Nerve Stimulators - Pipeline Products by Estimated Approval Date 10
Figure 5: Vagus Nerve Stimulators - Ongoing Clinical Trials 11

Filed in: Medical Device

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