Devices in the cerebrospinal fluid (CSF) management market are mainly used for the treatment of hydrocephalus. Hydrocephalus, or “water on the brain,” refers to an abnormal buildup of CSF in the brain’s ventricles. Under normal biological conditions, equilibrium between the production, circulation and absorption of CSF is maintained in the ventricular cavities of the brain as CSF is continually drained away into the circulatory system. Hydrocephalus can result when absorption of fluid into the bloodstream is blocked which leads to an accumulation of CSF. This condition can result in increased intracranial pressure inside of the skull and can lead to tunnel vision, mental disability, progressive enlargement of the head and even death. Symptoms due to the increased intracranial pressure include headaches, nausea, vomiting, papilledema, coma or sleepiness. Further elevation of intracranial pressure can result in uncal and/or cerebellar herniation.
For several years now there has been a shift from using fixed pressure shunts to pressure adjustable shunts. These shunts tend to have a lower revision rate and experience fewer complications, such as overdrainage, which makes them more popular among neurosurgeons and patients. However, fixed pressure shunts are still preferred by some neurosurgeons when treating pediatric patients. The fixed pressure devices are smaller and easier to use in these cases. The majority of shunts sold are pressure adjustable even though the ASP is also considerably higher for these devices. The move towards pressure adjustable shunts will continue over the forecast period as they cannibalize market share from fixed pressure shunts, increasing the market value. The ASP will continue to increase for pressure adjustable shunts as end-users switch to premium-priced products that have additional features such as antimicrobial coating. The ASP will remain relatively stable for fixed pressure shunts, with a slight appreciation due to the incorporation of new features.
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TABLE OF CONTENTS I
LIST OF FIGURES IX
LIST OF CHARTS XI
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
3.2 REGULATORY ISSUES AND RECALLS 53
3.2.1 Cerebrospinal Fluid Management 53
3.3 CLINICAL TRIALS 59
3.3.1 Cerebrospinal Fluid Management 59
CEREBROSPINAL FLUID MANAGEMENT MARKET 61
4.1 INTRODUCTION 61
4.2 MARKET OVERVIEW 64
4.3 MARKET ANALYSIS AND FORECAST 68
4.3.1 Total Cerebrospinal Fluid Management Market 68
4.3.2 Total Cerebrospinal Fluid Shunt Market 70
4.3.2.1 Pressure Adjustable Cerebrospinal Fluid Shunt Market 72
4.3.2.2 Fixed Pressure Cerebrospinal Fluid Shunt Market 74
4.3.3 Total Cerebrospinal Fluid External Drainage System Market 76
4.3.3.1 Ventricular Drainage System Market 78
4.3.3.2 Lumbar Drainage System Market 80
4.4 DRIVERS AND LIMITERS 82
4.4.1 Market Drivers 82
4.4.2 Market Limiters 83
4.5 COMPETITIVE MARKET SHARE ANALYSIS 86
ABBREVIATIONS 92
APPENDIX: COMPANY PRESS RELEASES 95
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
Chart 4 1: Cerebrospinal Fluid Management Market by Segment, U.S., 2013 – 2023 66
Chart 4 2: Cerebrospinal Fluid Management Market Breakdown, U.S., 2016 67
Chart 4 3: Cerebrospinal Fluid Management Market Breakdown, U.S., 2023 67
Chart 4 4: Total Cerebrospinal Fluid Management Market, U.S., 2013 – 2023 69
Chart 4 5: Cerebrospinal Fluid Shunt Market, U.S., 2013 – 2023 71
Chart 4 6: Pressure Adjustable Cerebrospinal Fluid Shunt Market, U.S., 2013 – 2023 73
Chart 4 7: Fixed Pressure Cerebrospinal Fluid Shunt Market, U.S., 2013 – 2023 75
Chart 4 8: Cerebrospinal Fluid External Drainage System Market, U.S., 2013 – 2023 77
Chart 4 9: Ventricular Drainage System Market, U.S., 2013 – 2023 79
Chart 4 10: Lumbar Drainage System Market, U.S., 2013 – 2023 81
Chart 4 11: Leading Competitors, Cerebrospinal Fluid Management Market, U.S., 2016 91
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. 53
Figure 3 3: Class 2 Device Recall: Aesculap Miethke Shunt System 53
Figure 3 4: Class 2 Device Recall: Aesculap Miethke Shunt System, miniNAV Valve 53
Figure 3 5: Class 2 Device Recall: Codman 54
Figure 3 6: Class 2 Device Recall: Codman Cetras 55
Figure 3 7: Class 2 Device Recall: Medtronic Duet External Drainage and Monitoring System 56
Figure 3 8: Class 2 Device Recall: Aesculap Inc. (AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System 56
Figure 3 9: Class 2 Device Recall: Aesculap 56
Figure 3 10: Class 2 Device Recall: Integra Cranial Access Kit 57
Figure 3 11: Class 2 Device Recall: Integra Cranial Access Kit 57
Figure 3 12: Class 2 Device Recall: CSFUnitized Shunt, Medtronic 57
Figure 3 13: Class 2 Device Recall: Aesculap(R) Miethke Shunt System 58
Figure 3 14: Class 2 Device Recall: Pudenz Flushing Valve 58
Figure 3 15: CSF Management: Strata Programmable CSF Shunt Valve Study 59
Figure 3 16: CSF Management: Cerebrospinal Fluid (CSF) Drainage Study 59
Figure 3 17: CSF Management: Lumbar Drainage in Subarachnoid Haemorrhage (LUMAS) 60
Figure 4 1: Cerebrospinal Fluid Management Market by Segment, U.S., 2013 – 2023 (US$M) 65
Figure 4 2: Cerebrospinal Fluid Shunt Market, U.S., 2013 – 2023 70
Figure 4 3: Pressure Adjustable Cerebrospinal Fluid Shunt Market, U.S., 2013 – 2023 72
Figure 4 4: Fixed Pressure Cerebrospinal Fluid Shunt Market, U.S., 2013 – 2023 74
Figure 4 5: Cerebrospinal Fluid External Drainage System Market, U.S., 2013 – 2023 76
Figure 4 6: Ventricular Drainage System Market, U.S., 2013 – 2023 78
Figure 4 7: Lumbar Drainage System Market, U.S., 2013 – 2023 80
Figure 4 8: Drivers and Limiters, Cerebrospinal Fluid Management Market, U.S., 2016 85
Figure 4 9: Leading Competitors, Cerebrospinal Fluid Management Market, U.S., 2016 90
Figure 6 1: Press Release Summary 95
Medtronic
Boston Scientific
St. Jude Medical
Cyberonics
Codman & Shurtleff
Stryker
Integra LifeSciences
InoMed
Mizuho America
RauMedic
