Liquid embolics currently on the market include N-butyl cyanoacrylate (NBCA) (TRUFILL®) and an ethylene-vinyl alcohol copolymer (Onyx®). These agents are injected through microcatheters and act like glue in abnormal blood vessels. When they contact blood they solidify and obstruct the vessel lumen therefore blocking the flow of blood through malformed blood vessels and reducing the risk of rupture. The surgeon performing the procedure must flush the catheter before and after injecting the NBCA to prevent the liquid agent from sticking to the catheter. Thus this procedure requires a highly skilled physician. This is often done prior to the removal of these vessels in order to simplify the surgical procedure.
There will be flat growth in the liquid embolics market over the forecast period. The, “A Randomized trial of Unruptured Brain Arteriovenous malformations” (ARUBA) trial compared interventional and conservative treatment of arteriovenous malformations in the brain. Conservative treatment consisted of a regimen of medication while the intervention arm included embolization. The trial was halted in 2013 due to excessive morbidity associated with the interventional arm. This outcome slowed growth in terms of unit sales in liquid embolics. Innovation in microcatheters to reduce complications in liquid embolic delivery may slightly increase unit sales. Overall growth in units sold will be flat. The total U.S. liquid embolic market includes TRUFILL n-BCA® from Codman & Shurtleff, Inc and Onyx® from Medtronic. Codman has been on the market for longer and tends to have slightly higher pricing however the ASP will be relatively flat over the projected period.
'
TABLE OF CONTENTS I
LIST OF FIGURES IX
LIST OF CHARTS X
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 Liquid Embolics 48
3.1.1.1 Introduction 48
3.1.1.2 Product Matrix for Liquid Embolics Market: Core Companies 50
3.2 REGULATORY ISSUES AND RECALLS 51
3.2.1 Liquid Embolics 51
3.3 CLINICAL TRIALS 52
3.3.1 Liquid Embolic 52
LIQUID EMBOLIC MARKET 53
4.1 INTRODUCTION 53
4.2 MARKET ANALYSIS AND FORECAST 55
4.3 DRIVERS AND LIMITERS 57
4.3.1 Market Drivers 57
4.3.2 Market Limiters 57
4.4 COMPETITIVE MARKET SHARE ANALYSIS 60
ABBREVIATIONS 63
APPENDIX: COMPANY PRESS RELEASES 66
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: Liquid Embolic Market, U.S., 2013 – 2023 56
Chart 4 2: Leading Competitors, Liquid Embolic Market, U.S., 2016 62
Medtronic
Boston Scientific
St. Jude Medical
Cyberonics
Codman & Shurtleff
Stryker
Integra LifeSciences
InoMed
Mizuho America
RauMedic