Spinal Cord Stimulators - Medical Devices Pipeline Assessment, 2017

Published : Jul-2017

No. of Pages : 105

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1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 6
2 Introduction 7
2.1 Spinal Cord Stimulators Overview 7
3 Products under Development 8
3.1 Spinal Cord Stimulators - Pipeline Products by Stage of Development 8
3.2 Spinal Cord Stimulators - Pipeline Products by Territory 9
3.3 Spinal Cord Stimulators - Pipeline Products by Regulatory Path 10
3.4 Spinal Cord Stimulators - Pipeline Products by Estimated Approval Date 11
3.5 Spinal Cord Stimulators - Ongoing Clinical Trials 12
4 Spinal Cord Stimulators - Pipeline Products under Development by Companies 13
4.1 Spinal Cord Stimulators Companies - Pipeline Products by Stage of Development 13
4.2 Spinal Cord Stimulators - Pipeline Products by Stage of Development 14
5 Spinal Cord Stimulators Companies and Product Overview 15
5.1 Cerevast Therapeutics Inc Company Overview 15
5.1.1 Cerevast Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 15
5.2 Direct Spinal Therapeutics, Inc. Company Overview 16
5.2.1 Direct Spinal Therapeutics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 16
5.3 Duke University Company Overview 17
5.3.1 Duke University Pipeline Products & Ongoing Clinical Trials Overview 17
5.4 G-Therapeutics SA Company Overview 18
5.4.1 G-Therapeutics SA Pipeline Products & Ongoing Clinical Trials Overview 18
5.5 Imperial College London Company Overview 21
5.5.1 Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 21
5.6 Mayo Clinic Company Overview 22
5.6.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 22
5.7 Meagan Medical Inc. Company Overview 23
5.7.1 Meagan Medical Inc. Pipeline Products & Ongoing Clinical Trials Overview 23
5.8 Medtrode Inc Company Overview 24
5.8.1 Medtrode Inc Pipeline Products & Ongoing Clinical Trials Overview 24
5.9 Medtronic plc Company Overview 25
5.9.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 25
5.10 MicroTransponder Inc. Company Overview 31
5.10.1 MicroTransponder Inc. Pipeline Products & Ongoing Clinical Trials Overview 31
5.11 NeuroRecovery Technologies Inc. Company Overview 32
5.11.1 NeuroRecovery Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 32
5.12 PathMaker Neurosystems Inc Company Overview 34
5.12.1 PathMaker Neurosystems Inc Pipeline Products & Ongoing Clinical Trials Overview 34
5.13 Saluda Medical Pty., Ltd. Company Overview 37
5.13.1 Saluda Medical Pty., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 37
5.14 St. Jude Medical LLC Company Overview 40
5.14.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 40
5.15 University of California Los Angeles Company Overview 46
5.15.1 University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 46
5.16 WISE S.r.l. Company Overview 47
5.16.1 WISE S.r.l. Pipeline Products & Ongoing Clinical Trials Overview 47
6 Spinal Cord Stimulators- Recent Developments 48
6.1 May 25, 2017: Medtronic Reports Fourth Quarter and Fiscal Year 2017 Financial Results 48
6.2 May 24, 2017: Stimwave Appoints Pat Tompkins as Executive Vice President of Sales 51
6.3 May 09, 2017: Nuvectra Reports First Quarter 2017 Financial Results 51
6.4 May 08, 2017: Nevro Reports First Quarter 2017 Financial Results 52
6.5 Apr 27, 2017: Boston Scientific Announces Results For First Quarter 2017 52
6.6 Apr 21, 2017: Stimwave Awarded U.S. Government DAPA Contract 54
6.7 Apr 07, 2017: Stimwave Announces Regulatory Approval from Australian Therapeutic Goods Administration (TGA) for its Freedom Spinal Cord Stimulation System 54
6.8 Apr 03, 2017: Man moves paralyzed legs using device that stimulates spinal cord 55
6.9 Mar 07, 2017: Nuvectra Reports Fourth Quarter and Full Year 2016 Financial Results 56
6.10 Feb 23, 2017: Nevro Reports Fourth Quarter and Full Year 2016 Financial Results and Provides 2017 Outlook 57
6.11 Feb 21, 2017: Medtronic Reports Third Quarter Financial Results 58
6.12 Feb 15, 2017: Bpifrance awards PathMaker Neurosystems a PIA Grant to Support Product Development 61
6.13 Feb 08, 2017: Alexander P. Hersel, M.D. and Bradley Spiegel, M.D., of Pain Management & Injury Relief Medical Center, achieve transformational results for back and leg pain with an innovative treatment 61
6.14 Feb 06, 2017: Medtronic Awarded U.S. Department of Veterans Affairs National Contracts for Home Telehealth Technologies, with Three Other Vendors 62
6.15 Feb 02, 2017: Boston Scientific Announces Results For Fourth Quarter And Full Year Ended December 31, 2016 63
6.16 Jan 23, 2017: PathMaker Neurosystems and France's Brain and Spine Institute Announce Establishment of Broad Relationship to Conduct European Clinical Trials for MyoRegulator 64
6.17 Jan 23, 2017: Analysis Of Data From Sunburst Study Confirms The Benefits Of Abbott's BurstDR Stimulation 65
6.18 Jan 20, 2017: New Study Demonstrates Spinal Cord Stimulation Can Reduce or Stabilize Opioid Use Among Chronic Pain Patients 66
6.19 Jan 18, 2017: Abbott Announces European Launch Of The Proclaim DRG Neurostimulation System For The Management Of Chronic Neuropathic Pain 67
6.20 Jan 17, 2017: New Data Confirms Abbott's Dorsal Root Ganglion Stimulation Offers Greater Treatment Success Over Traditional Spinal Cord Stimulation 68
6.21 Dec 13, 2016: Experimental Implant Shows Promise for Restoring Voluntary Movement after Spinal Cord Injury 69
6.22 Dec 13, 2016: Experimental implant shows promise for restoring voluntary movement after spinal cord injury 71
6.23 Dec 12, 2016: Nuvectra Corporation Signs Direct Supply Agreement 72
6.24 Dec 09, 2016: Nevro Announces Filing of Lawsuit by Boston Scientific 73
6.25 Dec 08, 2016: St. Jude Medical Receives CE Mark Approval for Full Body MR Conditional Labeling for the Proclaim Elite Spinal Cord Stimulation System 73
6.26 Nov 28, 2016: Nevro Files Lawsuit for Patent Infringement Against Boston Scientific in the U.S. 74
6.27 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 74
6.28 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 77
6.29 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 78
6.30 Nov 14, 2016: St. Jude Medical Announces Full-Body MRI Compatibility And Second Major Upgrade For Proclaim Elite Spinal Cord Stimulation System 78
6.31 Nov 09, 2016: Nuvectra Reports Third Quarter 2016 Financial Results 79
6.32 Nov 07, 2016: Nevro Reports Third Quarter 2016 Financial Results 80
6.33 Oct 26, 2016: Boston Scientific Announces Results For Third Quarter 2016 81
6.34 Oct 25, 2016: Southeast Pain Care is One of the First in North Carolina to Use New Neurostimulation Device for Chronic Pain 83
6.35 Oct 19, 2016: St. Jude Medical Reports Third Quarter 2016 Results 83
6.36 Oct 10, 2016: Professor Ian Meredith To Join Boston Scientific As Executive Vice President And Global Chief Medical Officer 85
6.37 Oct 04, 2016: St. Jude Medical Announces FDA Approval of BurstDR Stimulation, a New Superior Spinal Cord Stimulation Option for Patients Suffering from Chronic Pain 86
6.38 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 87
6.39 Sep 13, 2016: PathMaker Neurosystems Announces the Addition of Institute Professor Emilio Bizzi of MIT to its Scientific Advisory Board 88
6.40 Sep 06, 2016: Publication of Two-Year SENZA-RCT Results in Neurosurgery Demonstrates Sustained Superiority of HF10 Therapy over Traditional Spinal Cord Stimulation for Chronic Pain 88
6.41 Aug 29, 2016: Stimwave's Drug-Free Wireless Pain Relief Neurostimulator Changing the Lives of People Suffering From Chronic Pain 89
6.42 Aug 25, 2016: Medtronic Reports First Quarter Financial Results 91
6.43 Aug 23, 2016: Novel Technology for Veterans with Spinal Cord Injury or ALS to be presented at this year's Paralyzed Veterans of America Summit in Orlando: NeuRx Diaphragm Pacing System Shows Benefit In SCI and ALS Patients 93
6.44 Aug 10, 2016: Nuvectra Reports Second Quarter 2016 Financial Results 94
6.45 Aug 09, 2016: Synapse Biomedical Awarded GSA Schedule for NeuRx Diaphragm Pacing System product line; device will benefit veterans with spinal cord injury (SCI) and ALS 95
6.46 Aug 08, 2016: Nuvectra Announces Formation Of Medical Advisory Board 95
6.47 Aug 08, 2016: Nevro Reports Second Quarter 2016 Financial Results 96
6.48 Jul 28, 2016: Boston Scientific Announces Results For Second Quarter 2016 97
6.49 Jul 20, 2016: St. Jude Medical Reports Second Quarter 2016 Results 99
6.50 Jul 13, 2016: Boston Scientific Elects Yoshiaki Fujimori to Board of Directors 101
6.51 Jun 30, 2016: NuVasive Agrees to Settle Patent Litigation With Medtronic 101
7 Appendix 102
7.1 Methodology 102
7.2 About GlobalData 105
7.3 Contact Us 105
7.4 Disclaimer 105

1.1 List of Tables
Table 1: Spinal Cord Stimulators - Pipeline Products by Stage of Development 8
Table 2: Spinal Cord Stimulators - Pipeline Products by Territory 9
Table 3: Spinal Cord Stimulators - Pipeline Products by Regulatory Path 10
Table 4: Spinal Cord Stimulators - Pipeline Products by Estimated Approval Date 11
Table 5: Spinal Cord Stimulators - Ongoing Clinical Trials 12
Table 6: Spinal Cord Stimulators Companies - Pipeline Products by Stage of Development 13
Table 7: Spinal Cord Stimulators - Pipeline Products by Stage of Development 14
Table 8: Cerevast Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 15
Table 9: Transdermal Electrical Neurostimulation Device - Product Status 15
Table 10: Transdermal Electrical Neurostimulation Device - Product Description 15
Table 11: Direct Spinal Therapeutics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 16
Table 12: Iowa-Patch System - Product Status 16
Table 13: Iowa-Patch System - Product Description 16
Table 14: Duke University Pipeline Products & Ongoing Clinical Trials Overview 17
Table 15: Spinal Cord Stimulator - Product Status 17
Table 16: Spinal Cord Stimulator - Product Description 17
Table 17: G-Therapeutics SA Pipeline Products & Ongoing Clinical Trials Overview 18
Table 18: Implantable Neuro-Stimulation System - Product Status 18
Table 19: Implantable Neuro-Stimulation System - Product Description 18
Table 20: G-Therapeutics SA - Ongoing Clinical Trials Overview 19
Table 21: Implantable Neuro-Stimulation System - Feasibility Study: fMRI Evaluation of Auricular PENFS for Fibromyalgia 20
Table 22: Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 21
Table 23: Wireless Intraspinal Microstimulation System - Product Status 21
Table 24: Wireless Intraspinal Microstimulation System - Product Description 21
Table 25: Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 22
Table 26: Spinal Cord Electrical Stimulator - Product Status 22
Table 27: Spinal Cord Electrical Stimulator - Product Description 22
Table 28: Meagan Medical Inc. Pipeline Products & Ongoing Clinical Trials Overview 23
Table 29: DISCSS IFC System - Product Status 23
Table 30: DISCSS IFC System - Product Description 23
Table 31: Medtrode Inc Pipeline Products & Ongoing Clinical Trials Overview 24
Table 32: Implantable Pulse Generator - Product Status 24
Table 33: Implantable Pulse Generator - Product Description 24
Table 34: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 25
Table 35: Intellis RC - Product Status 25
Table 36: Intellis RC - Product Description 26
Table 37: MRI Surgical Lead - Product Status 26
Table 38: MRI Surgical Lead - Product Description 26
Table 39: PNS Device - Chronic Back Pain - Product Status 27
Table 40: PNS Device - Chronic Back Pain - Product Description 27
Table 41: PrimeADVANCED - Heart Failure - Product Status 27
Table 42: PrimeADVANCED - Heart Failure - Product Description 28
Table 43: Medtronic plc - Ongoing Clinical Trials Overview 29
Table 44: PrimeADVANCED - Heart Failure - Evaluation of Rate Adaptive Pacing on Chronotropic Response in Preserved Ejection Fraction HF 30
Table 45: MicroTransponder Inc. Pipeline Products & Ongoing Clinical Trials Overview 31
Table 46: SAINT System - Chronic Pain - Product Status 31
Table 47: SAINT System - Chronic Pain - Product Description 31
Table 48: NeuroRecovery Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 32
Table 49: External Spinal Cord Neuromodulation System - Product Status 32
Table 50: External Spinal Cord Neuromodulation System - Product Description 32
Table 51: Implantable Spinal Cord Stimulation Device - Product Status 33
Table 52: Implantable Spinal Cord Stimulation Device - Product Description 33
Table 53: PathMaker Neurosystems Inc Pipeline Products & Ongoing Clinical Trials Overview 34
Table 54: MyoRegulator PM-2200 - Product Status 34
Table 55: MyoRegulator PM-2200 - Product Description 34
Table 56: PathMaker Neurosystems Inc - Ongoing Clinical Trials Overview 35
Table 57: MyoRegulator PM-2200 - First Clinical Trial of MyoRegulator to Treat Muscle Contraction 36
Table 58: MyoRegulator PM-2200 - First European Clinical Trial of MyoRegulator to Treat Muscle Contraction 36
Table 59: MyoRegulator PM-2200 - The Effect of Treatment with the Pathmaker Myoregulator Neuromodulation System Incorporating Trans-spinal Direct Current Stimulation (tsDCS) in Patients with Severe Hand Spasticity after Stroke 36
Table 60: Saluda Medical Pty., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 37
Table 61: Evoke Spinal Cord Stimulator System - Product Status 37
Table 62: Evoke Spinal Cord Stimulator System - Product Description 37
Table 63: Saluda Medical Pty., Ltd. - Ongoing Clinical Trials Overview 38
Table 64: 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 39
Table 65: St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 40
Table 66: Next Generation Implantable SCS System - Primary Cell - Product Status 40
Table 67: Next Generation Implantable SCS System - Primary Cell - Product Description 40
Table 68: Next Generation Implantable SCS System - Rechargeable - Product Status 41
Table 69: Next Generation Implantable SCS System - Rechargeable - Product Description 41
Table 70: Proclaim Rechargeable Model - Product Status 41
Table 71: Proclaim Rechargeable Model - Product Description 41
Table 72: Proclaim Upgrade HC - Product Status 42
Table 73: Proclaim Upgrade HC - Product Description 42
Table 74: Proclaim Upgrade LC - Product Status 42
Table 75: Proclaim Upgrade LC - Product Description 43
Table 76: Prodigy SCS System - Product Status 43
Table 77: Prodigy SCS System - Product Description 43
Table 78: St. Jude Medical LLC - Ongoing Clinical Trials Overview 44
Table 79: Prodigy SCS System - Multi-center Prospective Study Determining the Sustainability of Pain Relief and Psychosocial and Functional Responses when Utilizing a Multiple Waveform Enabled Neurostimulator 45
Table 80: University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 46
Table 81: 32-Electrode Neurostimulator - Product Status 46
Table 82: 32-Electrode Neurostimulator - Product Description 46
Table 83: WISE S.r.l. Pipeline Products & Ongoing Clinical Trials Overview 47
Table 84: Foldable SCS Paddle Leads - Product Status 47
Table 85: Foldable SCS Paddle Leads - Product Description 47
Table 86: Glossary 104

1.2 List of Figures
Figure 1: Spinal Cord Stimulators - Pipeline Products by Stage of Development 8
Figure 2: Spinal Cord Stimulators - Pipeline Products by Territory 9
Figure 3: Spinal Cord Stimulators - Pipeline Products by Regulatory Path 10
Figure 4: Spinal Cord Stimulators - Pipeline Products by Estimated Approval Date 11
Figure 5: Spinal Cord Stimulators - Ongoing Clinical Trials 12

Filed in: Medical Device

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