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Vagus Nerve Stimulators - Medical Devices Pipeline Assessment, 2017

Vagus Nerve Stimulators - Medical Devices Pipeline Assessment, 2017

Summary

GlobalData's Medical Devices sector report, “Vagus Nerve Stimulators - Medical Devices Pipeline Assessment, 2017 provides an overview of Vagus Nerve Stimulators currently in pipeline stage.

The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Vagus Nerve Stimulators pipeline products.

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.

*Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

Scope

  • Extensive coverage of the Vagus Nerve Stimulators under development
  • The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities
  • The report reviews the major players involved in the development of Vagus Nerve Stimulators and list all their pipeline projects
  • The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage
  • The report provides key clinical trial data of ongoing trials specific to pipeline products
  • Recent developments in the segment / industry
Reasons to buy

The report enables you to -
  • Formulate significant competitor information, analysis, and insights to improve R&D strategies
  • Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage
  • Identify and understand important and diverse types of Vagus Nerve Stimulators under development
  • Develop market-entry and market expansion strategies
  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline
  • In-depth analysis of the product’s current stage of development, territory and estimated launch date


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

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