Neurovascular catheters, also known as microcatheters, are a type of catheter small enough to be used in neurovascular procedures. The devices are very narrow in order to traverse the fine vessels within the brain. Microcatheters are designed with several properties in mind: hydrophilic coating, softness, trackability and stability. Neurovascular catheters are to deliver detachable coils, stents, liquid embolics and pharmaceutical products directly to the brain. They are often used for treating aneurysms, arteriovenous malformations (AVMs), trauma and strokes. Microcatheters are offered with different varieties of tips, which allow physicians to choose the appropriate tip for a specific location in the brain. The devices also vary in diameter, which is measured in French (F) size, where one F is equal to 0.33 mm. Although tip and diameter can vary widely, microcatheters are grouped by guiding systems. There are three types of microcatheters: over-the-wire, flow directed including the new detachable tip versions and guide catheters.
The total neurovascular catheter market includes over-the-wire and flow-guided microcatheters, as well as guiding catheters. Steady increases in unit sales over the forecast period are expected to drive growth. Neurovascular catheters are used to deliver various neurovascular devices to the brain. As a result, neurovascular catheters are used in numerous cranial procedures. As neurological procedure numbers increase, so will the need for interventional products such as neurovascular catheters. Innovation in the treatment of ischemic stroke with new technology like stent retrievers and flow diverting stents will drive an increase in the number of catheters required as well. In addition there is the more established market for coil and liquid embolization devices. The over-the-wire microcatheters account for the largest proportion of the market value and unit sales. The guiding catheters make up the second largest proportion of both. Sales of flow-guided microcatheters comprised the remaining portion. The latter is expected to experience slower growth than over-the-wire and guiding catheters as it is primarily used for the delivery of liquid embolics whereas the other two categories are used for significantly more procedures.
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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 Neurovascular Catheters 48
3.1.1.1 Introduction 48
3.1.1.2 Product Matrix for Neurovascular Catheter Market: Core Companies 50
3.2 REGULATORY ISSUES AND RECALLS 51
3.2.1 Neurovascular Catheters 51
3.3 CLINICAL TRIALS 53
3.3.1 Neurovascular Catheters 53
NEUROVASCULAR CATHETER MARKET 54
4.1 INTRODUCTION 54
4.2 MARKET OVERVIEW 56
4.3 MARKET ANALYSIS AND FORECAST 60
4.3.1 Over-the-Wire Microcatheter Market 60
4.3.2 Flow-Directed Microcatheter Market 62
4.3.3 Neurovascular Guiding Catheter Market 64
4.4 DRIVERS AND LIMITERS 66
4.4.1 Market Drivers 66
4.4.2 Market Limiters 67
4.5 COMPETITIVE MARKET SHARE ANALYSIS 69
ABBREVIATIONS 74
APPENDIX: COMPANY PRESS RELEASES 77
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: Neurovascular Catheter Market by Segment, U.S., 2013 – 2023 58
Chart 4 2: Neurovascular Catheter Market Breakdown, U.S., 2016 59
Chart 4 3: Neurovascular Catheter Market Breakdown, U.S., 2023 59
Chart 4 4: Over-the-Wire Microcatheter Market, U.S., 2013 – 2023 61
Chart 4 5: Flow-Directed Microcatheter Market, U.S., 2013 – 2023 63
Chart 4 6: Neurovascular Guiding Catheter Market, U.S., 2013 – 2023 65
Chart 4 7: Leading Competitors, Neurovascular Catheter Market, U.S., 2016 73
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: Class 2 Device Recall: Distal Access Catheter 51
Figure 3 2: Class 2 Device Recall COMPLIANT, Stryker Neurovascular 51
Figure 3 3: Class 2 Device Recall EXCELSIOR, Stryker Neurovascular 52
Figure 3 4: Neurovascular Catheters: Quality Control: A Prospective Analysis of EVD Effectiveness 53
Figure 4 1: Neurovascular Catheter Market by Segment, U.S., 2013 – 2023 57
Figure 4 2: Over-the-Wire Microcatheter Market, U.S., 2013 – 2023 60
Figure 4 3: Flow-Directed Microcatheter Market, U.S., 2013 – 2023 62
Figure 4 4: Neurovascular Guiding Catheter Market, U.S., 2013 – 2023 64
Figure 4 5: Drivers and Limiters, Neurovascular Catheter Market, U.S., 2016 68
Figure 4 6: Leading Competitors, Neurovascular Catheter Market, U.S., 2016 72
Figure 6 1: Press Release Summary 77
Medtronic
Boston Scientific
St. Jude Medical
Cyberonics
Codman & Shurtleff
Stryker
Integra LifeSciences
InoMed
Mizuho America
RauMedic
