Ischemic Stroke is caused by an obstruction within a blood vessel that is supplying blood to the brain. This is often caused by blood clots but can also be caused by other substances like plaque. The gold standard treatment for strokes for many years has been the administration of clot dissolving or clot busting medication called tissue plasminogen activator (tPA). This type of drug must be administered as soon as possible, with a four hour window from symptom onset, to increase chances of recovery. A significant number of patients do not get to healthcare facilities quickly enough to meet that window and even some of those who do, later experience hemorrhagic complications from the medication. It is very effective for smaller clots but often fails to break up larger clots. Some patients cannot receive tPA, in which cases physicians rely on antiplatelet or anticoagulant medicine to ensure blood clots do not get larger.
There will be significant market growth in the mechanical thrombectomy market over the forecast period, driven by growth in unit sales as mechanical thrombectomy is adopted as standard of care for acute ischemic stroke patients. This market includes stent retrievers and suction thrombectomy catheters. The majority of the time a combination of the two categories is used but there a number of factors that can impact treatment decisions, one key factor being physician preference. Studies found new stent retriever devices are superior to first generation aspiration devices but there have been fewer studies comparing the second generation of both categories. Prior to 2012 it was mainly aspiration used and then with the entrance of stent retrievers, they became the primary treatment. In the last year or so, combination therapy has become the most common. Both categories of devices have a role as certain devices appear to more successful based on the anatomy, clot morphology and clot locations. Additional clinical trials will influence whether the devices continue to be used in conjunction or whether one category will cannibalize shares form the other.
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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 Mechanical Thrombectomy 48
3.1.1.1 Introduction 48
3.1.1.2 Product Matrix for Mechanical Trombectomy device: Core Companies 51
3.2 REGULATORY ISSUES AND RECALLS 52
3.2.1 Mechanical Thrombectomy 52
3.3 CLINICAL TRIALS 53
3.3.1 Mechanical Thrombectomy 53
MECHANICAL THROMBECTOMY MARKET 56
4.1 INTRODUCTION 56
4.2 MARKET OVERVIEW 59
4.3 MARKET ANALYSIS AND FORECAST 63
4.3.1 Stent Retrievers 63
4.3.2 Thrombectomy Catheters 65
4.4 DRIVERS AND LIMITERS 67
4.4.1 Market Drivers 67
4.4.2 Market Limiters 68
4.5 COMPETITIVE MARKET SHARE ANALYSIS 69
ABBREVIATIONS 72
APPENDIX: COMPANY PRESS RELEASES 75
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: Mechanical Thrombectomy Market by Segment, U.S., 2013 – 2023 61
Chart 4 2: Mechanical Thrombectomy Market Breakdown, U.S., 2016 62
Chart 4 3: Mechanical Thrombectomy Market Breakdown, U.S., 2023 62
Chart 4 4: Stent Retriever Market, U.S., 2013 – 2023 64
Chart 4 5: Thrombectomy Catheter Market, U.S., 2013 – 2023 66
Chart 4 6: Leading Competitors, Mechanical Thrombectomy Market, U.S., 2016 71
Medtronic
Boston Scientific
St. Jude Medical
Cyberonics
Codman & Shurtleff
Stryker
Integra LifeSciences
InoMed
Mizuho America
RauMedic