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

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

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.

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.


EXECUTIVE SUMMARY
U.S. NEUROMODULATION, NEUROVASCULAR, NEUROSURGICAL AND MONITORING DEVICE MARKET OVERVIEW
COMPETITIVE ANALYSIS
MARKET TRENDS
MARKET DEVELOPMENTS
PROCEDURE NUMBERS
PROCEDURE CODES INVESTIGATED
MARKETS INCLUDED
KEY REPORT UPDATES
VERSION HISTORY
RESEARCH METHODOLOGY
1.1 RESEARCH SCOPE
1.2 IDATA’S 9-STEP METHODOLOGY
Step 1: Project Initiation & Team Selection
Step 2: Prepare Data Systems and Perform Secondary Research
Step 3: Preparation for Interviews & Questionnaire Design
Step 4: Performing Primary Research
Step 5: Research Analysis: Establishing Baseline Estimates
Step 6: Market Forecast and Analysis
Step 7: Identify Strategic Opportunities
Step 8: Final Review and Market Release
Step 9: Customer Feedback and Market Monitoring
DISEASE OVERVIEW
2.1 BASIC ANATOMY
2.2 DISEASE PATHOLOGY AND DISORDERS
2.2.1 Introduction
2.2.2 General Diagnostics and Neurosurgery
2.2.3 Tumor and Brain Cancer
2.2.4 Brain Arteriovenous Malformations
2.2.5 Ischemic Stroke
2.2.6 Brain Aneurysm
2.2.7 Disorders Related to Cerebrospinal Fluids and Intracranial Pressure
2.2.7.1 Hydrocephalus and Intracranial Pressure Disorder
2.2.7.2 Cerebral Edema
2.2.8 Indication for Neuromodulation
2.2.9 Traumatic brain injury
PRODUCT ASSESSMENT
3.1 PRODUCT PORTFOLIOS
3.1.1 Cerebrospinal Fluid Management
3.1.1.1 Introduction
3.1.1.2 Product Matrix for CFS Management market: Core Companies (1 of 2)
3.1.1.3 Product Matrix for CFS Management market: Core Companies (2 of 2)
3.1.2 Intracranial Pressure Monitoring
3.1.2.1 Introduction
3.1.2.2 Product Matrix for ICP Monitoring Market: Core Companies (1 of 2)
3.1.2.3 Product Matrix for ICP Monitoring Market: Core Companies (2 of 2)
3.1.3 Detachable Coils
3.1.3.1 Introduction
3.1.3.2 Product Matrix for Detachable Coils Market: Core Companies
3.1.4 Liquid Embolics
3.1.4.1 Introduction
3.1.4.2 Product Matrix for Liquid Embolics Market: Core Companies
3.1.5 Neurovascular Catheters
3.1.5.1 Introduction
3.1.5.2 Product Matrix for Neurovascular Catheter Market: Core Companies
3.1.6 Neurovascular Guidewires
3.1.6.1 Introduction
3.1.6.2 Product Matrix for Neurovascular Guidewires Market: Core Companies
3.1.7 Neurovascular Stent
3.1.7.1 Introduction
3.1.7.2 Product Matrix for Neurovascular Stent Market: Core Companies
3.1.8 Balloon Occlusion Devices
3.1.8.1 Introduction
3.1.8.2 Product Matrix for Balloon Occlusion Device Market: Core Companies
3.1.9 Neuromodulation Devices
3.1.9.1 Introduction
3.1.9.2 Spinal Cord Stimulators
3.1.9.3 Vagus Nerve Stimulators
3.1.9.4 Deep Brain Stimulators
3.1.9.5 Gastric Electric Stimulators
3.1.9.6 Sacral Nerve Stimulators
3.1.9.7 Product Matrix for Neuromodulation Device Market: Core Companies
3.1.10 Neuroendoscopy Devices
3.1.10.1 Introduction
3.1.10.2 Product Matrix for Neuroendoscopy: Core Companies
3.1.11 Stereotactic Devices
3.1.11.1 Introduction
3.1.11.2 Product Matrix for Stereotactic Devices: Core Companies
3.1.12 Ultrasonic Aspiration Devices
3.1.12.1 Introduction
3.1.12.2 Product Matrix for Ultraconic Aspiration Device: Core Companies
3.1.13 Aneurysm Clip
3.1.13.1 Introduction
3.1.13.2 Product Matrix for Aneurysm Clip Device: Core Companies
3.1.14 Neurological Microscopes
3.1.14.1 Introduction
3.1.14.2 Product Matrix for Aneurysm Clip device: Core Companies
3.1.15 Intrathecal Pumps
3.1.15.1 Introduction
3.1.15.2 Product Matrix for Intrathecal Pump device: Core Companies
3.1.16 Mechanical Thrombectomy
3.1.16.1 Introduction
3.1.16.2 Product Matrix for Mechanical Trombectomy device: Core Companies
3.2 REGULATORY ISSUES AND RECALLS
3.2.1 Cerebrospinal Fluid Management
3.2.2 Intracranial Pressure (ICP) Monitoring
3.2.3 Detachable Coils
3.2.4 Liquid Embolics
3.2.5 Neurovascular Catheters
3.2.6 Neurovascular Guidewires
3.2.7 Neurovascular Stent
3.2.8 Balloon Occlusion Devices
3.2.9 Neuromodulation Devices
3.2.10 Neuroendoscopy
3.2.11 Stereotactic Devices
3.2.12 Ultrasonic Aspiration
3.2.13 Aneurysm Clip
3.2.14 Neurological Microscopes
3.2.15 Intrathecal Pumps
3.2.16 Mechanical Thrombectomy
3.3 CLINICAL TRIALS
3.3.1 Cerebrospinal Fluid Management
3.3.2 Intracranial Pressure Monitoring
3.3.3 Detachable Coils
3.3.4 Liquid Embolic
3.3.5 Neurovascular Catheters
3.3.6 Neurovascular Stent
3.3.7 Balloon Occlusion Devices
3.3.8 Neuromodulation Devices
3.3.9 Neuroendoscopy
3.3.10 Stereotactic Devices
3.3.11 Ultrasonic Aspiration
3.3.12 Aneurysm Clip
3.3.13 Neurological Microscopes
3.3.14 Intrathecal Pumps
3.3.15 Mechanical Thrombectomy
ABBREVIATIONS
APPENDIX: COMPANY PRESS RELEASES
List of Charts
Chart 1 1: Neurological Device Market by Segment, U.S., 2013 – 2023
Chart 1 2: Neurological Device Market Overview, U.S., 2016 & 2023
List of Figures
Figure 1 1: Neurological Device Market Share Ranking by Segment, U.S., 2016 (1 of 3)
Figure 1 2: Neurological Device Market Share Ranking by Segment, U.S., 2016 (2 of 3)
Figure 1 3: Neurological Device Market Share Ranking by Segment, U.S., 2016 (3 of 3)
Figure 1 4: Companies Researched in this Report, U.S., 2016
Figure 1 5: Factors Impacting the Neurological Device Market by Segment, U.S. (1 of 3)
Figure 1 6: Factors Impacting the Neurological Device Market by Segment, U.S. (2 of 3)
Figure 1 7: Factors Impacting the Neurological Device Market by Segment, U.S. (3 of 3)
Figure 1 8: Recent Events in the Neurological Device Market, U.S., 2014 – 2016
Figure 1 9: Neurological Device Markets Covered, U.S., 2016
Figure 1 10: Procedural Codes Investigated, U.S., 2016 (1 of 2)
Figure 1 11: Procedural Codes Investigated, U.S., 2016 (2 of 2)
Figure 1 12: Neurological Device Markets Covered, U.S., 2016 (1 of 2)
Figure 1 13: Neurological Device Markets Covered, U.S., 2016 (2 of 2)
Figure 1 14: Key Report Updates
Figure 1 15: Version History
Figure 2 1: Neurology Disease Overview
Figure 2 2: Brain/Other Nervous System Cancer Statistics by Type and Gender, U.S., 2016
Figure 3 1: Shunt Types
Figure 3 2: Class 2 Device Recall: VentriClear II Ventricular Drainage Catheter Set, Cook Inc.
Figure 3 3: Class 2 Device Recall: Aesculap Miethke Shunt System
Figure 3 4: Class 2 Device Recall: Aesculap Miethke Shunt System, miniNAV Valve
Figure 3 5: Class 2 Device Recall: Codman
Figure 3 6: Class 2 Device Recall: Codman Cetras
Figure 3 7: Class 2 Device Recall: Medtronic Duet External Drainage and Monitoring System
Figure 3 8: Class 2 Device Recall: Aesculap Inc. (AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System
Figure 3 9: Class 2 Device Recall: Aesculap
Figure 3 10: Class 2 Device Recall: Integra Cranial Access Kit
Figure 3 11: Class 2 Device Recall: Integra Cranial Access Kit
Figure 3 12: Class 2 Device Recall: CSFUnitized Shunt, Medtronic
Figure 3 13: Class 2 Device Recall: Aesculap(R) Miethke Shunt System
Figure 3 14: Class 2 Device Recall: Pudenz Flushing Valve
Figure 3 15: Class 2 Device Recall: Intracranial pressure monitor
Figure 3 16: Class 2 Device Recall: Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting
Figure 3 17: Class 2 Device Recall: Integra Camino 1104 Intracranial Pressure (ICP) Monitoring
Figure 3 18: Class 2 Device Recall: Integra
Figure 3 19: Class 2 Device Recall: Integra Camino 1104 ICP Monitoring
Figure 3 20: Class 2 Device Recall: Codman
Figure 3 21: Class 2 Device Recall: Target Detachable Coils, Stryker Neurovascular
Figure 3 22: Class 2 Device Recall: GDC 360 Detachable Coil, Stryker Neurovascular
Figure 3 23: Class 2 Device Recall: Stryker Neurovascular
Figure 3 24: Class 2 Device Recall: GDC, Stryker Neurovascular
Figure 3 25: Class 3 Device Recall: Axium Detachable Coil System QC21Helix
Figure 3 26: Class 1 Device Recall: Penumbra Coil System, Penumbra Coil 400
Figure 3 27: Class 1 Device Recall: nButyl Cyanoacrylate (nBCA) Liquid Embolic System (TRUFILL, Codman)
Figure 3 28: Class 2 Device Recall: Distal Access Catheter
Figure 3 29: Class 2 Device Recall COMPLIANT, Stryker Neurovascular
Figure 3 30: Class 2 Device Recall EXCELSIOR, Stryker Neurovascular
Figure 3 31: Class 1 Device Recall: THUNDER Steerable Guidewire
Figure 3 32: Class 2 Device Recall: Fathom14 Steerable Guidewire Peripheral Vascular Use, 200 cm x 10 cm
Figure 3 33: Class 2 Device Recall: Pipeline and Pipeline Flex
Figure 3 34: Class 2 Device Recall: Stryker brand Neuroform 3 Microdelivery Stent System
Figure 3 35: Class 2 Device Recall: Wingspan Stent System
Figure 3 36: Class 2 Device Recall: FlowGate Balloon Guide Catheter, Concentric Medical Inc.
Figure 3 37: Class 2 Device Recall: Concentric 7F Balloon Guide Catheter
Figure 3 38: Class 2 Device Recall: RestoreSensor and RestoreSensor SureScan, Medtronic Neuromodulation
Figure 3 39: Class 2 Device Recall: DBS Pocket Adaptor, Medtronic Neuromodulation
Figure 3 40: Class 2 Device Recall: Specify neurostimulation leads, Medtronic Neuromodulation
Figure 3 41: Class 2 Device Recall: Itrel 3 IPG; InterStim II INS: InterStim INS ; Enterra INS
Figure 3 42: Class 2 Device Recall: Percutaneous Trial Lead Kits, St. Jude Medical, Inc.
Figure 3 43: Class 2 Device Recall: Brio DBS System, Advanced Neuromodulation Systems Inc.
Figure 3 44: Class 2 Device Recall: RestoreUltra and RestoreSensor, Medtronic Neuromodulation
Figure 3 45: Class 2 Device Recall: VSII, Visionsense, Ltd.
Figure 3 46: Class 2 Device Recall: ASSISTO, Geomed Medizin-Technik Gmbh & Co.
Figure 3 47: Class 3 Device Recall: Channel Neuroendoscope, Medtronic Neurosurgery
Figure 3 48: Class 2 Device Recall: StealthStation System, Medtronic Navigation, Inc.
Figure 3 49: Class 2 Device Recall: Leksell Gamma Knife Perfexion and Leksell Gamma Knife Icon, Elekta, Inc
Figure 3 50: Class 2 Device Recall: Brainlab Cranial Navigation System, Brainlab AG
Figure 3 51: Class 2 Device Recall: Brainlab AG
Figure 3 52: Class 2 Device Recall: Brainlab
Figure 3 53: Class 2 Device Recall: Stereotactic Circular Collimator 3D Line stereotactic Hardware Accessories
Figure 3 54: Class 2 Device Recall: 43410 FRAMELESS SRS QA TARGET POINTER
Figure 3 55: Class 2 Device Recall: Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning
Figure 3 56: Class 2 Device Recall: CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL)
Figure 3 57: Class 2 Device Recall: Integra LifeSciences Corp.
Figure 3 58: Class 2 Device Recall: Sonopet Ultrasonic Aspirator Console, Stryker Corporation
Figure 3 59: Class 2 Device Recall: Integra CUSA Excel Sterile Torque Wrench (23 kHz)
Figure 3 60: Class 2 Device Recall:
Figure 3 61: Class 2 Device Recall: Integra CEM Nosecones
Figure 3 62: Class 2 Device Recall: Mizuho Sugita Titanium Standard Aneurysm Clip II Temporary
Figure 3 63: Class 2 Device Recall: Casper Clip Appliers, Aesculap Inc.
Figure 3 64: Class 2 Device Recall: Polarizer D Fixed w/Rotating Red 1 lambda plate, Carl Zeiss, LCC
Figure 3 65: Class 2 Device Recall: Surgical microscope
Figure 3 66: Class 1 Device Recall Medtronic SynchroMed
Figure 3 67: Class 2 Device Recall: Trevo Pro 4 Stent Retriever
Figure 3 68: CSF Management: Strata Programmable CSF Shunt Valve Study
Figure 3 69: CSF Management: Cerebrospinal Fluid (CSF) Drainage Study
Figure 3 70: CSF Management: Lumbar Drainage in Subarachnoid Haemorrhage (LUMAS)
Figure 3 71: ICP Monitoring: Assessing the Accuracy and the Impact of Standard-practice Ventricular Drainage on ICP Measurements
Figure 3 72: ICP Monitoring: Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma (GMaPIC)
Figure 3 73: ICP Monitoring: Non-invasive Intracranial Pressure (ICP) Monitoring in Pediatric Patients
Figure 3 74: ICP Monitoring: Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion
Figure 3 75: ICP Monitoring: An Evaluation of Non-invasive ICP Monitoring
Figure 3 76: ICP Monitoring: An Evaluation of Non-Invasive ICP Monitoring
Figure 3 77: ICP Monitoring: Prospective Evaluation of the Non-invasive ICP HeadSense Monitor
Figure 3 78: ICP Monitoring: Non-invasive Brain Pressure Monitoring After Trauma or Hemorrhage
Figure 3 79: ICP Monitoring: NIMI-NICU: Non Invasive Monitoring of the Intracranial Pressure - NeuroIntensive Care Unit
Figure 3 80: Detachable Coils: Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil (SMART)
Figure 3 81: Detachable Coils: DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial
Figure 3 82: Detachable Coils: Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT)
Figure 3 83: Detachable Coils: Hydrogel Endovascular Aneurysm Treatment Trial (HEAT)
Figure 3 84: Detachable Coils: Prospective Packing Density With Target Coils I (PropackI)
Figure 3 85: Detachable Coils: COAST: Coiling of Aneurysms Smaller Than 5mm With Hypersoft® (COAST)
Figure 3 86: Detachable Coils: A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System in France (VOLCAN)
Figure 3 87: Detachable Coils: Study of the Penumbra Coil 400 System to Treat Aneurysm (ACE)
Figure 3 88: Detachable Coils: Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry (GELATIN)
Figure 3 89: Detachable Coils: TARGET Intracranial Aneurysm Coiling Registry (TARGET)
Figure 3 90: Detachable Coils: HydroCoil Cerebral Aneurysm Treatment Trial (HCAT)
Figure 3 91: Detachable Coils: Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms
Figure 3 92: Liquid Embolic: Apollo™ Onyx™ Delivery Micro Catheter Post Market Safety Study
Figure 3 93: Liquid Embolic: Safety of Apollo Micro Catheter in Pediatric Patients
Figure 3 94: Liquid Embolic: TRUfill®'s Line in Intracranial aNeurysm Embolisation (TRULINE)
Figure 3 95: Neurovascular Catheters: Quality Control: A Prospective Analysis of EVD Effectiveness
Figure 3 96: Neurovascular Stent: Safety and Effectiveness of an Intracranial Aneurysm Embolization System
Figure 3 97: Neurovascular Stent: Study of the Reverse Medical Barrel™ Vascular Reconstruction Device (VRD)
Figure 3 98: Neurovascular Stent: Flow Diverter Stent for Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms (EVIDENCE)
Figure 3 99: Neurovascular Stent: Complete Occlusion of Coilable Aneurysms (COCOA)
Figure 3 100: Neurovasculr Stents: VISSIT Intracranial Stent Study for Ischemic Therapy (VISSIT)
Figure 3 101: Neurovasculr Stents: The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System (SUNRISE)
Figure 3 102: Neurovasculr Stents: Enterprise Stent Aneurysm Treatment (ESAT) Study - France (ESAT)
Figure 3 103: Balloon Occlusion Device: TransForm™ Occlusion Balloon Catheter Registry
Figure 3 104: Neuromodulation device: The Motor Network in Essential Tremor: Mechanisms of Therapy
Figure 3 105: Neuromodulation device: Treatment of Bipolar Depression With H1-Coil Deep Brain rTMS
Figure 3 106: Neuromodulation device: A Pilot Study of Deep Brain Stimulation of the Amygdala
Figure 3 107: Neuromodulation device: MAPS Trial: Matrix And Platinum Science (MAPS)
Figure 3 108: Neuroendoscopy: A Study Comparing Two Treatments for Infants With Hydrocephalus
Figure 3 109: Neuroendoscopy: Multicenter Clinical Study on Diagnosis and Treatment of Skull Base Trauma
Figure 3 110: Neuroendoscopy: Comparison Between Stereotactic Aspiration and Intra-endoscopic Surgery
Figure 3 111: Stereotactic Device: Panobinostat and Stereotactic Radiation Therapy in Treating Patients With Brain Tumors
Figure 3 112: Stereotactic Device: Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations
Figure 3 113: Ultrasonic Aspiration: European Registry on the ACE Reperfusion Catheters and the Penumbra System
Figure 3 114: Aneurysm Clip: DIVERT: Diversion of Flow in Intracranial VErtebral
Figure 3 115: Aneurysm Clip: Rapid Ventricular Pacing in Surgical Treatment of Intracranial Aneurysms
Figure 3 116: Aneurysm Clip: Barrow Ruptured Aneurysm Trial (BRAT)
Figure 3 117: Aneurysm Clip: Safety Study of Minimally Invasive Approaches
Figure 3 118: Neurological Microscope: Autofluorescent Flavoprotein Imaging of Intraepidermal Nerve Fibers: a Pilot Study
Figure 3 119: Intrathecal Pumps: Long-term Surveillance of the MedStream Programmable Infusion System
Figure 3 120: Mechanical Trombectomy: Comparison of Thrombectomy and Standard Care for Ischemic Stroke
Figure 3 121: Mechanical Trombectomy: Interest of Direct Aspiration First Pass Technique (ADAPT)
Figure 3 122: Mechanical Trombectomy: Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy
Figure 3 123: Mechanical Trombectomy: Evaluation of the ReVive SE Device for Intra-Arterial Thrombectomy in Acute Ischemic Stroke
Figure 3 124: Mechanical Trombectomy: Trial and Cost Effectiveness Evaluation of Intra-arterial Thrombectomy
Figure 5 1: Press Release Summary

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