Detachable coil embolization is a minimally invasive method of treating brain aneurysms and cerebral blood vessel malformations. The detachable coil embolization treatment of cerebral aneurysms is less invasive and requires less recovery time than open surgery. An aneurysm is a weakened area in the wall of an artery in the brain. This area bulges in the artery and if it ruptures it can lead to a bleed in the brain and cause stroke, brain damage and even death. Interventional neuroradiologists will typically perform the detachable coil embolization process to alleviate dangers associated with aneurysms.
Coiling has emerged as the primary treatment method for aneurysms and continues to replace aneurysm clipping. The transition from clipping to coiling led to rapid market growth market early in the century but coiling is forecasted to reach its saturation point in the next few years.
The market comprises bare platinum and coated detachable coils. Although coated coils sell for a premium, their adoption has been limited due to a lack of evidence of their superiority when compared to bare platinum coils. Trials such as the MAPS and Cerecyte failed to show a superior efficacy for coated coils over bare platinum coils and as a result the use of coated coils has been decreasing. It is estimated that 90% of total unit sales of coils are bare platinum coils and that this trend will continue unless clinical evidence demonstrates health benefits from coated coils.
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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 Detachable Coils 48
3.1.1.1 Introduction 48
3.1.1.2 Product Matrix for Detachable Coils Market: Core Companies 50
3.2 REGULATORY ISSUES AND RECALLS 51
3.2.1 Detachable Coils 51
3.3 CLINICAL TRIALS 54
3.3.1 Detachable Coils 54
DETACHABLE COIL MARKET 58
4.1 INTRODUCTION 58
4.2 MARKET OVERVIEW 60
4.3 MARKET ANALYSIS AND FORECAST 63
4.3.1 Total Detachable Coil Market 63
4.3.1.1 Bare Platinum Detachable Coil Market 65
4.3.1.2 Coated Detachable Coil 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: Detachable Coil Market by Segment, U.S., 2013 – 2023 61
Chart 4 2: Detachable Coil Market Breakdown, U.S., 2016 62
Chart 4 3: Detachable Coil Market Breakdown, U.S., 2023 62
Chart 4 4: Total Detachable Coil Market, U.S., 2013 – 2023 64
Chart 4 5: Bare Platinum Detachable Coil Market, U.S., 2013 – 2023 66
Chart 4 6: Coated Detachable Coil Market, U.S., 2013 – 2023 68
Chart 4 7: Leading Competitors, Detachable Coil Market, U.S., 2016 75
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: Target Detachable Coils, Stryker Neurovascular 51
Figure 3 2: Class 2 Device Recall: GDC 360 Detachable Coil, Stryker Neurovascular 51
Figure 3 3: Class 2 Device Recall: Stryker Neurovascular 52
Figure 3 4: Class 2 Device Recall: GDC, Stryker Neurovascular 52
Figure 3 5: Class 3 Device Recall: Axium Detachable Coil System QC21Helix 52
Figure 3 6: Class 1 Device Recall: Penumbra Coil System, Penumbra Coil 400 52
Figure 3 7: Detachable Coils: Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil (SMART) 54
Figure 3 8: Detachable Coils: DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial 54
Figure 3 9: Detachable Coils: Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT) 55
Figure 3 10: Detachable Coils: Hydrogel Endovascular Aneurysm Treatment Trial (HEAT) 55
Figure 3 11: Detachable Coils: Prospective Packing Density With Target Coils I (PropackI) 55
Figure 3 12: Detachable Coils: COAST: Coiling of Aneurysms Smaller Than 5mm With Hypersoft® (COAST) 55
Figure 3 13: Detachable Coils: A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System in France (VOLCAN) 56
Figure 3 14: Detachable Coils: Study of the Penumbra Coil 400 System to Treat Aneurysm (ACE) 56
Figure 3 15: Detachable Coils: Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry (GELATIN) 56
Figure 3 16: Detachable Coils: TARGET Intracranial Aneurysm Coiling Registry (TARGET) 56
Figure 3 17: Detachable Coils: HydroCoil Cerebral Aneurysm Treatment Trial (HCAT) 57
Figure 3 18: Detachable Coils: Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms 57
Figure 4 1: Detachable Coil Market by Segment, U.S., 2013 – 2023 (US$M) 60
Figure 4 2: Total Detachable Coil Market, U.S., 2013 – 2023 63
Figure 4 3: Bare Platinum Detachable Coil Market, U.S., 2013 – 2023 65
Figure 4 4: Coated Detachable Coil Market, U.S., 2013 – 2023 67
Figure 4 5: Drivers and Limiters, Detachable Coil Market, U.S., 2016 71
Figure 4 6: Leading Competitors, Detachable Coil Market, U.S., 2016 74
Figure 6 1: Press Release Summary 79
Medtronic
Boston Scientific
St. Jude Medical
Cyberonics
Codman & Shurtleff
Stryker
Integra LifeSciences
InoMed
Mizuho America
RauMedic
