Balloon occlusion devices have inflatable balloon devices at their distal end which can be expanded to occlude an artery. Balloon occlusion devices serve a number of purposes in neurovascular procedures. They can be used to assist detachable coil procedures, similarly to stents, however these devices are temporary. In these cases they are being used to aid in the treatment of aneurysms, AVMs or fistulas. When using detachable coils there is a risk of the coils blocking flow of the parent artery if they occlude the lumen of the artery as well. In order to minimize this risk, the balloon is inflated inside the parent artery prior to the insertion of coils so that they can be packed tighter inside the aneurysm without the danger of them protruding into the lumen. A study looking at this technique in anterior aneurysms found that there was a lower complication rate with balloon assisted coiling in comparison to coiling alone however other studies have found the opposite therefore further studies are required. In some cases, balloon catheters can also be used for the placement of stents. There are a number of factors that could impact the choice to use this device for aneurysm treatment such as the clinical situation, physician’s preference, and the morphology of the aneurysm. It is worth noting that the ASP of these devices is considerably less than stents which could impact device preference as well.
Balloon occlusion devices will experience low single digit market growth over the forecast period. They will experience steady growth in units sold due to their many applications. As coils continue to increase in popularity over the next few years it will drive growth in balloon assisted coiling. This technique is still more popular than stent assisted coiling which may be due to the significantly lower ASP these devices command. The ASP of balloon occlusion devices has risen slightly over the past few years but is expected to remain steady over the forecast period.
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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 Balloon Occlusion Devices 48
3.1.1.1 Introduction 48
3.1.1.2 Product Matrix for Balloon Occlusion Device Market: Core Companies 50
3.2 REGULATORY ISSUES AND RECALLS 51
3.2.1 Balloon Occlusion Devices 51
3.3 CLINICAL TRIALS 52
3.3.1 Balloon Occlusion Devices 52
BALLOON OCCLUSION DEVICE 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 59
ABBREVIATIONS 62
APPENDIX: COMPANY PRESS RELEASES 65
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: Balloon Occlusion Device Market, U.S., 2013 – 2023 56
Chart 4 2: Leading Competitors, Balloon Occlusion Device Market, U.S., 2016 61
Medtronic
Boston Scientific
St. Jude Medical
Cyberonics
Codman & Shurtleff
Stryker
Integra LifeSciences
InoMed
Mizuho America
RauMedic
