US Product Portfolio for Neuromodulation, Neurovascular, Neurosurgical and Monitoring Devices 2017 - MedFolio

iData Research
162 Pages - IDR10358
$1,995.00

The full report suite on the U.S. market for neurological devices includes cerebrospinal fluid shunts, cerebrospinal fluid external drainage systems, intracranial pressure monitoring devices, detachable coils, liquid embolics, catheters, guidewires, balloon occlusion devices, neurovascular stents and flow diversion stents, spinal cord stimulators, vagus nerve stimulators, sacral nerve stimulators, deep brain stimulators, gastric electric stimulators, neuroendoscopes, stereotactic frames, stereotactic frameless systems, ultrasonic aspirators, aneurysm clips, neurosurgical microscopes, intrathecal pumps and mechanical thrombectomy devices.

Stereotaxy has become the standard of care in neurosurgery therefore the market for stereotactic systems is saturated, limiting growth in market value. Innovative technology and updated features and software will be required to encourage growth. New competitors have entered the neuromodulation market which will drive competitive pressure in technological advancement and pricing. This will have the greatest impact on the spinal cord stimulator and deep brain stimulator markets. One of the major market drivers for neurological devices is the patient and physicians demand for minimally invasive procedures. This has been driving the growth in interventional neuroradiology and neuroendoscopy. This has led to procedural growth in endovascular embolization treatments and a decline in aneurysm clipping procedures treatments. Access devices are becoming increasingly technologically advanced and various embolization devices have been released in recent years. One of the major emerging trends is the growth of mechanical thrombectomy devices for ischemic stroke. These devices extend the window for treatment of patients compared to medical therapy alone and can provide dramatically improved clinical outcomes.

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TABLE OF CONTENTS I
LIST OF FIGURES XI
LIST OF CHARTS XVII
EXECUTIVE SUMMARY 1
U.S. NEUROMODULATION, NEUROVASCULAR, NEUROSURGICAL AND MONITORING DEVICE MARKET OVERVIEW 1
COMPETITIVE ANALYSIS 4
MARKET TRENDS 8
MARKET DEVELOPMENTS 11
PROCEDURE NUMBERS 12
PROCEDURE CODES INVESTIGATED 13
MARKETS INCLUDED 15
KEY REPORT UPDATES 17
VERSION HISTORY 17
RESEARCH METHODOLOGY 18
1.1 RESEARCH SCOPE 18
1.2 IDATA’S 9-STEP METHODOLOGY 18
Step 1: Project Initiation & Team Selection 18
Step 2: Prepare Data Systems and Perform Secondary Research 20
Step 3: Preparation for Interviews & Questionnaire Design 21
Step 4: Performing Primary Research 22
Step 5: Research Analysis: Establishing Baseline Estimates 24
Step 6: Market Forecast and Analysis 25
Step 7: Identify Strategic Opportunities 27
Step 8: Final Review and Market Release 28
Step 9: Customer Feedback and Market Monitoring 29
DISEASE OVERVIEW 30
2.1 BASIC ANATOMY 30
2.2 DISEASE PATHOLOGY AND DISORDERS 32
2.2.1 Introduction 32
2.2.2 General Diagnostics and Neurosurgery 34
2.2.3 Tumor and Brain Cancer 36
2.2.4 Brain Arteriovenous Malformations 38
2.2.5 Ischemic Stroke 39
2.2.6 Brain Aneurysm 40
2.2.7 Disorders Related to Cerebrospinal Fluids and Intracranial Pressure 42
2.2.7.1 Hydrocephalus and Intracranial Pressure Disorder 42
2.2.7.2 Cerebral Edema 43
2.2.8 Indication for Neuromodulation 45
2.2.9 Traumatic brain injury 47
PRODUCT ASSESSMENT 48
3.1 PRODUCT PORTFOLIOS 48
3.1.1 Cerebrospinal Fluid Management 48
3.1.1.1 Introduction 48
3.1.1.2 Product Matrix for CFS Management market: Core Companies (1 of 2) 51
3.1.1.3 Product Matrix for CFS Management market: Core Companies (2 of 2) 52
3.1.2 Intracranial Pressure Monitoring 53
3.1.2.1 Introduction 53
3.1.2.2 Product Matrix for ICP Monitoring Market: Core Companies (1 of 2) 55
3.1.2.3 Product Matrix for ICP Monitoring Market: Core Companies (2 of 2) 56
3.1.3 Detachable Coils 57
3.1.3.1 Introduction 57
3.1.3.2 Product Matrix for Detachable Coils Market: Core Companies 59
3.1.4 Liquid Embolics 60
3.1.4.1 Introduction 60
3.1.4.2 Product Matrix for Liquid Embolics Market: Core Companies 62
3.1.5 Neurovascular Catheters 63
3.1.5.1 Introduction 63
3.1.5.2 Product Matrix for Neurovascular Catheter Market: Core Companies 64
3.1.6 Neurovascular Guidewires 65
3.1.6.1 Introduction 65
3.1.6.2 Product Matrix for Neurovascular Guidewires Market: Core Companies 66
3.1.7 Neurovascular Stent 67
3.1.7.1 Introduction 67
3.1.7.2 Product Matrix for Neurovascular Stent Market: Core Companies 69
3.1.8 Balloon Occlusion Devices 70
3.1.8.1 Introduction 70
3.1.8.2 Product Matrix for Balloon Occlusion Device Market: Core Companies 71
3.1.9 Neuromodulation Devices 72
3.1.9.1 Introduction 72
3.1.9.2 Spinal Cord Stimulators 72
3.1.9.3 Vagus Nerve Stimulators 73
3.1.9.4 Deep Brain Stimulators 74
3.1.9.5 Gastric Electric Stimulators 75
3.1.9.6 Sacral Nerve Stimulators 76
3.1.9.7 Product Matrix for Neuromodulation Device Market: Core Companies 78
3.1.10 Neuroendoscopy Devices 79
3.1.10.1 Introduction 79
3.1.10.2 Product Matrix for Neuroendoscopy: Core Companies 81
3.1.11 Stereotactic Devices 82
3.1.11.1 Introduction 82
3.1.11.2 Product Matrix for Stereotactic Devices: Core Companies 84
3.1.12 Ultrasonic Aspiration Devices 85
3.1.12.1 Introduction 85
3.1.12.2 Product Matrix for Ultraconic Aspiration Device: Core Companies 86
3.1.13 Aneurysm Clip 87
3.1.13.1 Introduction 87
3.1.13.2 Product Matrix for Aneurysm Clip Device: Core Companies 88
3.1.14 Neurological Microscopes 89
3.1.14.1 Introduction 89
3.1.14.2 Product Matrix for Aneurysm Clip device: Core Companies 90
3.1.15 Intrathecal Pumps 91
3.1.15.1 Introduction 91
3.1.15.2 Product Matrix for Intrathecal Pump device: Core Companies 93
3.1.16 Mechanical Thrombectomy 94
3.1.16.1 Introduction 94
3.1.16.2 Product Matrix for Mechanical Trombectomy device: Core Companies 96
3.2 REGULATORY ISSUES AND RECALLS 97
3.2.1 Cerebrospinal Fluid Management 97
3.2.2 Intracranial Pressure (ICP) Monitoring 103
3.2.3 Detachable Coils 105
3.2.4 Liquid Embolics 108
3.2.5 Neurovascular Catheters 109
3.2.6 Neurovascular Guidewires 111
3.2.7 Neurovascular Stent 112
3.2.8 Balloon Occlusion Devices 113
3.2.9 Neuromodulation Devices 114
3.2.10 Neuroendoscopy 116
3.2.11 Stereotactic Devices 117
3.2.12 Ultrasonic Aspiration 120
3.2.13 Aneurysm Clip 122
3.2.14 Neurological Microscopes 123
3.2.15 Intrathecal Pumps 124
3.2.16 Mechanical Thrombectomy 125
3.3 CLINICAL TRIALS 126
3.3.1 Cerebrospinal Fluid Management 126
3.3.2 Intracranial Pressure Monitoring 128
3.3.3 Detachable Coils 133
3.3.4 Liquid Embolic 138
3.3.5 Neurovascular Catheters 140
3.3.6 Neurovascular Stent 141
3.3.7 Balloon Occlusion Devices 145
3.3.8 Neuromodulation Devices 146
3.3.9 Neuroendoscopy 148
3.3.10 Stereotactic Devices 150
3.3.11 Ultrasonic Aspiration 151
3.3.12 Aneurysm Clip 152
3.3.13 Neurological Microscopes 154
3.3.14 Intrathecal Pumps 155
3.3.15 Mechanical Thrombectomy 156
ABBREVIATIONS 159
APPENDIX: COMPANY PRESS RELEASES 162

Chart 1 1: Neurological Device Market by Segment, U.S., 2013 – 2023 3
Chart 1 2: Neurological Device Market Overview, U.S., 2016 & 2023 3

Figure 1 1: Neurological Device Market Share Ranking by Segment, U.S., 2016 (1 of 3) 5
Figure 1 2: Neurological Device Market Share Ranking by Segment, U.S., 2016 (2 of 3) 5
Figure 1 3: Neurological Device Market Share Ranking by Segment, U.S., 2016 (3 of 3) 6
Figure 1 4: Companies Researched in this Report, U.S., 2016 7
Figure 1 5: Factors Impacting the Neurological Device Market by Segment, U.S. (1 of 3) 8
Figure 1 6: Factors Impacting the Neurological Device Market by Segment, U.S. (2 of 3) 9
Figure 1 7: Factors Impacting the Neurological Device Market by Segment, U.S. (3 of 3) 10
Figure 1 8: Recent Events in the Neurological Device Market, U.S., 2014 – 2016 11
Figure 1 9: Neurological Device Markets Covered, U.S., 2016 12
Figure 1 10: Procedural Codes Investigated, U.S., 2016 (1 of 2) 13
Figure 1 11: Procedural Codes Investigated, U.S., 2016 (2 of 2) 14
Figure 1 12: Neurological Device Markets Covered, U.S., 2016 (1 of 2) 15
Figure 1 13: Neurological Device Markets Covered, U.S., 2016 (2 of 2) 16
Figure 1 14: Key Report Updates 17
Figure 1 15: Version History 17
Figure 2 1: Neurology Disease Overview 33
Figure 2 2: Brain/Other Nervous System Cancer Statistics by Type and Gender, U.S., 2016 37
Figure 3 1: Shunt Types 49
Figure 3 2: Class 2 Device Recall: VentriClear II Ventricular Drainage Catheter Set, Cook Inc. 97
Figure 3 3: Class 2 Device Recall: Aesculap Miethke Shunt System 97
Figure 3 4: Class 2 Device Recall: Aesculap Miethke Shunt System, miniNAV Valve 97
Figure 3 5: Class 2 Device Recall: Codman 98
Figure 3 6: Class 2 Device Recall: Codman Cetras 99
Figure 3 7: Class 2 Device Recall: Medtronic Duet External Drainage and Monitoring System 100
Figure 3 8: Class 2 Device Recall: Aesculap Inc. (AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System 100
Figure 3 9: Class 2 Device Recall: Aesculap 100
Figure 3 10: Class 2 Device Recall: Integra Cranial Access Kit 101
Figure 3 11: Class 2 Device Recall: Integra Cranial Access Kit 101
Figure 3 12: Class 2 Device Recall: CSFUnitized Shunt, Medtronic 101
Figure 3 13: Class 2 Device Recall: Aesculap(R) Miethke Shunt System 102
Figure 3 14: Class 2 Device Recall: Pudenz Flushing Valve 102
Figure 3 15: Class 2 Device Recall: Intracranial pressure monitor 103
Figure 3 16: Class 2 Device Recall: Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting 103
Figure 3 17: Class 2 Device Recall: Integra Camino 1104 Intracranial Pressure (ICP) Monitoring 103
Figure 3 18: Class 2 Device Recall: Integra 103
Figure 3 19: Class 2 Device Recall: Integra Camino 1104 ICP Monitoring 104
Figure 3 20: Class 2 Device Recall: Codman 104
Figure 3 21: Class 2 Device Recall: Target Detachable Coils, Stryker Neurovascular 105
Figure 3 22: Class 2 Device Recall: GDC 360 Detachable Coil, Stryker Neurovascular 106
Figure 3 23: Class 2 Device Recall: Stryker Neurovascular 106
Figure 3 24: Class 2 Device Recall: GDC, Stryker Neurovascular 106
Figure 3 25: Class 3 Device Recall: Axium Detachable Coil System QC21Helix 107
Figure 3 26: Class 1 Device Recall: Penumbra Coil System, Penumbra Coil 400 107
Figure 3 27: Class 1 Device Recall: nButyl Cyanoacrylate (nBCA) Liquid Embolic System (TRUFILL, Codman) 108
Figure 3 28: Class 2 Device Recall: Distal Access Catheter 109
Figure 3 29: Class 2 Device Recall COMPLIANT, Stryker Neurovascular 109
Figure 3 30: Class 2 Device Recall EXCELSIOR, Stryker Neurovascular 110
Figure 3 31: Class 1 Device Recall: THUNDER Steerable Guidewire 111
Figure 3 32: Class 2 Device Recall: Fathom"14 Steerable Guidewire Peripheral Vascular Use, 200 cm x 10 cm 111
Figure 3 33: Class 2 Device Recall: Pipeline and Pipeline Flex 112
Figure 3 34: Class 2 Device Recall: Stryker brand Neuroform 3 Microdelivery Stent System 112
Figure 3 35: Class 2 Device Recall: Wingspan Stent System 112
Figure 3 36: Class 2 Device Recall: FlowGate Balloon Guide Catheter, Concentric Medical Inc. 113
Figure 3 37: Class 2 Device Recall: Concentric 7F Balloon Guide Catheter 113
Figure 3 38: Class 2 Device Recall: RestoreSensor and RestoreSensor SureScan, Medtronic Neuromodulation 114
Figure 3 39: Class 2 Device Recall: DBS Pocket Adaptor, Medtronic Neuromodulation 114
Figure 3 40: Class 2 Device Recall: Specify neurostimulation leads, Medtronic Neuromodulation 114
Figure 3 41: Class 2 Device Recall: Itrel 3 IPG; InterStim II INS: InterStim INS ; Enterra INS 115
Figure 3 42: Class 2 Device Recall: Percutaneous Trial Lead Kits, St. Jude Medical, Inc. 115
Figure 3 43: Class 2 Device Recall: Brio DBS System, Advanced Neuromodulation Systems Inc. 115
Figure 3 44: Class 2 Device Recall: RestoreUltra and RestoreSensor, Medtronic Neuromodulation 115
Figure 3 45: Class 2 Device Recall: VSII, Visionsense, Ltd. 116
Figure 3 46: Class 2 Device Recall: ASSISTO, Geomed Medizin-Technik Gmbh & Co. 116
Figure 3 47: Class 3 Device Recall: Channel Neuroendoscope, Medtronic Neurosurgery 116
Figure 3 48: Class 2 Device Recall: StealthStation System, Medtronic Navigation, Inc. 117
Figure 3 49: Class 2 Device Recall: Leksell Gamma Knife Perfexion and Leksell Gamma Knife Icon, Elekta, Inc 117
Figure 3 50: Class 2 Device Recall: Brainlab Cranial Navigation System, Brainlab AG 118
Figure 3 51: Class 2 Device Recall: Brainlab AG 118
Figure 3 52: Class 2 Device Recall: Brainlab 118
Figure 3 53: Class 2 Device Recall: Stereotactic Circular Collimator 3D Line stereotactic Hardware Accessories 119
Figure 3 54: Class 2 Device Recall: 43410 FRAMELESS SRS QA TARGET POINTER 119
Figure 3 55: Class 2 Device Recall: Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning 119
Figure 3 56: Class 2 Device Recall: CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL) 119
Figure 3 57: Class 2 Device Recall: Integra LifeSciences Corp. 120
Figure 3 58: Class 2 Device Recall: Sonopet Ultrasonic Aspirator Console, Stryker Corporation 120
Figure 3 59: Class 2 Device Recall: Integra CUSA Excel Sterile Torque Wrench (23 kHz) 120
Figure 3 60: Class 2 Device Recall: 121
Figure 3 61: Class 2 Device Recall: Integra CEM Nosecones 121
Figure 3 62: Class 2 Device Recall: Mizuho Sugita Titanium Standard Aneurysm Clip II Temporary 122
Figure 3 63: Class 2 Device Recall: Casper Clip Appliers, Aesculap Inc. 122
Figure 3 64: Class 2 Device Recall: Polarizer D Fixed w/Rotating Red 1 lambda plate, Carl Zeiss, LCC 123
Figure 3 65: Class 2 Device Recall: Surgical microscope 123
Figure 3 66: Class 1 Device Recall Medtronic SynchroMed 124
Figure 3 67: Class 2 Device Recall: Trevo Pro 4 Stent Retriever 125
Figure 3 68: CSF Management: Strata Programmable CSF Shunt Valve Study 126
Figure 3 69: CSF Management: Cerebrospinal Fluid (CSF) Drainage Study 126
Figure 3 70: CSF Management: Lumbar Drainage in Subarachnoid Haemorrhage (LUMAS) 127
Figure 3 71: ICP Monitoring: Assessing the Accuracy and the Impact of Standard-practice Ventricular Drainage on ICP Measurements 128
Figure 3 72: ICP Monitoring: Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma (GMaPIC) 128
Figure 3 73: ICP Monitoring: Non-invasive Intracranial Pressure (ICP) Monitoring in Pediatric Patients 129
Figure 3 74: ICP Monitoring: Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion 129
Figure 3 75: ICP Monitoring: An Evaluation of Non-invasive ICP Monitoring 130
Figure 3 76: ICP Monitoring: An Evaluation of Non-Invasive ICP Monitoring 130
Figure 3 77: ICP Monitoring: Prospective Evaluation of the Non-invasive ICP HeadSense Monitor 131
Figure 3 78: ICP Monitoring: Non-invasive Brain Pressure Monitoring After Trauma or Hemorrhage 131
Figure 3 79: ICP Monitoring: NIMI-NICU: Non Invasive Monitoring of the Intracranial Pressure - NeuroIntensive Care Unit 132
Figure 3 80: Detachable Coils: Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil (SMART) 133
Figure 3 81: Detachable Coils: DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial 133
Figure 3 82: Detachable Coils: Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT) 134
Figure 3 83: Detachable Coils: Hydrogel Endovascular Aneurysm Treatment Trial (HEAT) 134
Figure 3 84: Detachable Coils: Prospective Packing Density With Target Coils I (PropackI) 134
Figure 3 85: Detachable Coils: COAST: Coiling of Aneurysms Smaller Than 5mm With Hypersoft® (COAST) 135
Figure 3 86: Detachable Coils: A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System in France (VOLCAN) 135
Figure 3 87: Detachable Coils: Study of the Penumbra Coil 400 System to Treat Aneurysm (ACE) 135
Figure 3 88: Detachable Coils: Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry (GELATIN) 136
Figure 3 89: Detachable Coils: TARGET Intracranial Aneurysm Coiling Registry (TARGET) 136
Figure 3 90: Detachable Coils: HydroCoil Cerebral Aneurysm Treatment Trial (HCAT) 136
Figure 3 91: Detachable Coils: Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms 137
Figure 3 92: Liquid Embolic: Apollo™ Onyx™ Delivery Micro Catheter Post Market Safety Study 138
Figure 3 93: Liquid Embolic: Safety of Apollo Micro Catheter in Pediatric Patients 138
Figure 3 94: Liquid Embolic: TRUfill®'s Line in Intracranial aNeurysm Embolisation (TRULINE) 139
Figure 3 95: Neurovascular Catheters: Quality Control: A Prospective Analysis of EVD Effectiveness 140
Figure 3 96: Neurovascular Stent: Safety and Effectiveness of an Intracranial Aneurysm Embolization System 141
Figure 3 97: Neurovascular Stent: Study of the Reverse Medical Barrel™ Vascular Reconstruction Device (VRD) 141
Figure 3 98: Neurovascular Stent: Flow Diverter Stent for Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms (EVIDENCE) 142
Figure 3 99: Neurovascular Stent: Complete Occlusion of Coilable Aneurysms (COCOA) 142
Figure 3 100: Neurovasculr Stents: VISSIT Intracranial Stent Study for Ischemic Therapy (VISSIT) 143
Figure 3 101: Neurovasculr Stents: The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System (SUNRISE) 143
Figure 3 102: Neurovasculr Stents: Enterprise Stent Aneurysm Treatment (ESAT) Study - France (ESAT) 144
Figure 3 103: Balloon Occlusion Device: TransForm™ Occlusion Balloon Catheter Registry 145
Figure 3 104: Neuromodulation device: The Motor Network in Essential Tremor: Mechanisms of Therapy 146
Figure 3 105: Neuromodulation device: Treatment of Bipolar Depression With H1-Coil Deep Brain rTMS 146
Figure 3 106: Neuromodulation device: A Pilot Study of Deep Brain Stimulation of the Amygdala 147
Figure 3 107: Neuromodulation device: MAPS Trial: Matrix And Platinum Science (MAPS) 147
Figure 3 108: Neuroendoscopy: A Study Comparing Two Treatments for Infants With Hydrocephalus 148
Figure 3 109: Neuroendoscopy: Multicenter Clinical Study on Diagnosis and Treatment of Skull Base Trauma 148
Figure 3 110: Neuroendoscopy: Comparison Between Stereotactic Aspiration and Intra-endoscopic Surgery 149
Figure 3 111: Stereotactic Device: Panobinostat and Stereotactic Radiation Therapy in Treating Patients With Brain Tumors 150
Figure 3 112: Stereotactic Device: Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations 150
Figure 3 113: Ultrasonic Aspiration: European Registry on the ACE Reperfusion Catheters and the Penumbra System 151
Figure 3 114: Aneurysm Clip: DIVERT: Diversion of Flow in Intracranial VErtebral 152
Figure 3 115: Aneurysm Clip: Rapid Ventricular Pacing in Surgical Treatment of Intracranial Aneurysms 152
Figure 3 116: Aneurysm Clip: Barrow Ruptured Aneurysm Trial (BRAT) 153
Figure 3 117: Aneurysm Clip: Safety Study of Minimally Invasive Approaches 153
Figure 3 118: Neurological Microscope: Autofluorescent Flavoprotein Imaging of Intraepidermal Nerve Fibers: a Pilot Study 154
Figure 3 119: Intrathecal Pumps: Long-term Surveillance of the MedStream Programmable Infusion System 155
Figure 3 120: Mechanical Trombectomy: Comparison of Thrombectomy and Standard Care for Ischemic Stroke 156
Figure 3 121: Mechanical Trombectomy: Interest of Direct Aspiration First Pass Technique (ADAPT) 156
Figure 3 122: Mechanical Trombectomy: Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy 157
Figure 3 123: Mechanical Trombectomy: Evaluation of the ReVive SE Device for Intra-Arterial Thrombectomy in Acute Ischemic Stroke 157
Figure 3 124: Mechanical Trombectomy: Trial and Cost Effectiveness Evaluation of Intra-arterial Thrombectomy 158
Figure 5 1: Press Release Summary 162

Medtronic
Boston Scientific
St. Jude Medical
Cyberonics
Codman & Shurtleff
Stryker
Integra LifeSciences
InoMed
Mizuho America
RauMedic

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