There are two main types of neurovascular stents currently on the market, the traditional stent and the flow diverter stent. They are both used as treatments for cerebral aneurysms. Traditional neurovascular stents are small, flexible, tube-like devices used for stabilizing detachable coils within an aneurysm. They serve to block off the aneurysm and to prevent coils from slipping back into the main blood vessel. These stents are also used to treat intracranial stenosis by opening blocked arteries. These stents are delivered in reduced tube structures for easier navigation and delivery through the narrow intracranial vessels. As brain arteries are more fragile than carotid arteries, a self-expanding stent that gently opens to the desired vessel diameter is generally used. Self-expandable stents carry a lower risk of dissection or vessel rupture when compared to the balloon-expandable stents.
High single digit market growth will be seen throughout the forecast period for neurovascular stents as next generation devices continue to enter the U.S. market. Traditional coil assisted stenting will continue to grow in unit sales while flow diversion stenting, a new and promising endovascular treatment, will experience rapid growth as well. Sales of these devices in the U.S. only began in 2011 following the approval of the Pipeline™ device from Medtronic. Flow diversion stents have the potential to cannibalize a portion of traditional stent sales but they will both continue to experience growth. These increases in unit sales will also be driven by innovation in these devices making them smaller and able to place in more distal locations. The high market value is in part attributable to the fact that flow diversion stents command an ASP of nearly twice that of a traditional stent. Both types of stents are expected to experience marginal increases in pricing due to innovation, which will also drive market growth.
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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 Stent 48
3.1.1.1 Introduction 48
3.1.1.2 Product Matrix for Neurovascular Stent Market: Core Companies 51
3.2 REGULATORY ISSUES AND RECALLS 52
3.2.1 Neurovascular Stent 52
3.3 CLINICAL TRIALS 53
3.3.1 Neurovascular Stent 53
NEUROVASCULAR STENT MARKET 57
4.1 INTRODUCTION 57
4.2 MARKET OVERVIEW 59
4.3 MARKET ANALYSIS AND FORECAST 62
4.3.1 Total Neurovascular Stent Market 62
4.3.2 Traditional Neurovascular Stent Market 64
4.3.3 Flow Diversion Stent Market 67
4.4 DRIVERS AND LIMITERS 69
4.4.1 Market Drivers 69
4.4.2 Market Limiters 70
4.5 COMPETITIVE MARKET SHARE ANALYSIS 72
ABBREVIATIONS 76
APPENDIX: COMPANY PRESS RELEASES 79
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 Stent Market, U.S., 2013 – 2023 60
Chart 4 2: Neurovascular Stent Market Breakdown, U.S., 2016 61
Chart 4 3: Neurovascular Stent Market Breakdown, U.S., 2023 61
Chart 4 4: Total Neurovascular Stent Market, U.S., 2013 – 2023 63
Chart 4 5: Traditional Neurovascular Stent Market, U.S., 2013 – 2023 66
Chart 4 6: Flow Diversion Stent Market, U.S., 2013 – 2023 68
Chart 4 7: Leading Competitors, Neurovascular Stent Market, U.S., 2016 75
Medtronic
Boston Scientific
St. Jude Medical
Cyberonics
Codman & Shurtleff
Stryker
Integra LifeSciences
InoMed
Mizuho America
RauMedic