Dialysis catheters are used for facilitating dialysis for patients whose kidneys are unable to properly filter water and waste. Most patients treated with dialysis have been diagnosed with end-stage renal disease (ESRD); however, patients suffering from acute kidney failure can also receive dialysis. Glomerular filtration rate (GFR) is a test used to assess kidney function. In turn, patients with chronically low GFRs are diagnosed with chronic kidney disease (CKD). When the GFR drops below the threshold, which is when kidney activity is less than 10% of normal levels, patients are considered to have progressed to Stage 5 CKD or ESRD. Patients with ESRD require a kidney transplant or dialysis. However, many ESRD patients are not suitable candidates for kidney transplants.
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TABLE OF CONTENTS I
LIST OF FIGURES XVII
LIST OF CHARTS XXII
EXECUTIVE SUMMARY 1
EUROPEAN MARKET FOR VASCULAR ACCESS DEVICES AND ACCESSORIES OVERVIEW 1
COMPETITIVE ANALYSIS 3
MARKET TRENDS 5
MARKET DEVELOPMENTS 6
PROCEDURE NUMBERS 7
MARKETS INCLUDED 8
KEY REPORT UPDATES 11
VERSION HISTORY 12
RESEARCH METHODOLOGY 13
1.1 RESEARCH SCOPE 13
1.2 IDATA’S 9-STEP METHODOLOGY 13
Step 1: Project Initiation & Team Selection 13
Step 2: Prepare Data Systems and Perform Secondary Research 15
Step 3: Preparation for Interviews & Questionnaire Design 16
Step 4: Performing Primary Research 17
Step 5: Research Analysis: Establishing Baseline Estimates 19
Step 6: Market Forecast and Analysis 20
Step 7: Identify Strategic Opportunities 22
Step 8: Final Review and Market Release 23
Step 9: Customer Feedback and Market Monitoring 24
DISEASE OVERVIEW 25
2.1 BASIC ANATOMY 25
2.1.1 Human Vascular System 25
2.2 VASCULAR PATHOLOGY AND DISORDERS 26
2.2.1 Cancer 26
2.2.2 End-Stage Renal Disease 27
2.2.3 Diabetes 29
PRODUCT ASSESSMENT 32
3.1 PRODUCT PORTFOLIOS 32
3.1.1 Dialysis Catheters 32
3.1.1.1 Introduction 32
3.1.1.1.1 AV Fistulae 33
3.1.1.1.2 AV Grafts 33
3.1.1.1.3 Dialysis Catheters 34
3.1.1.2 AngioDynamics 36
3.1.1.2.1 DuraMax® 36
3.1.1.2.2 DuraFlow™ 36
3.1.1.2.3 Schon™ 36
3.1.1.2.4 Other Dialysis Catheter Offerings 36
3.1.1.3 Argon Medical 36
3.1.1.3.1 UltraStream™ 36
3.1.1.4 Baxter 37
3.1.1.4.1 GamCath™ 37
3.1.1.5 Cook Medical 37
3.1.1.5.1 Turbo-Flo® 37
3.1.1.5.2 Tenckhoff™ 37
3.1.1.6 C.R. Bard 37
3.1.1.6.1 EQUISTREAM® 37
3.1.1.6.2 HemoSplit® 37
3.1.1.6.3 HemoStar® 38
3.1.1.6.4 Niagara™ 38
3.1.1.6.5 Other Dialysis Catheter Offerings 38
3.1.1.7 Marvao Medical 38
3.1.1.7.1 NexSite™ 38
3.1.1.8 Medcomp 38
3.1.1.8.1 Split Cath® 38
3.1.1.8.2 Hemo-Cath® 39
3.1.1.8.3 Hemo-Flow® 39
3.1.1.8.4 Other Dialysis Catheter Offerings 39
3.1.1.9 Medtronic 39
3.1.1.9.1 MAHURKAR™ 39
3.1.1.9.2 Palindrome™ 39
3.1.1.9.3 Other Dialysis Catheter Offerings 40
3.1.1.10 Merit Medical 40
3.1.1.10.1 Flex-Neck® 40
3.1.1.10.2 Centros™ 40
3.1.1.10.3 ProGuide™ 40
3.1.1.11 PFM Medical 40
3.1.1.11.1 Veta™ 40
3.1.1.12 Phase One Medical 40
3.1.1.12.1 Symetrex™ 40
3.1.1.13 Teleflex Medical 41
3.1.1.13.1 NextStep® 41
3.1.1.13.2 VectorFlow™ 41
3.1.1.13.3 Other Dialysis Catheter Offerings 41
3.2 REGULATORY ISSUES AND RECALLS 42
3.2.1 November 2015 42
3.2.2 October 2015 42
3.2.3 September 2015 43
3.2.4 August 2015 45
3.2.5 July 2015 46
3.2.6 April 2015 48
3.2.7 March 2015 49
3.2.8 February 2015 50
3.2.9 January 2015 50
3.2.10 December 2014 51
3.2.11 October 2014 52
3.2.12 September 2014 53
3.2.13 May 2014 54
3.2.14 April 2014 54
3.2.15 March 2014 55
3.2.16 January 2014 55
3.2.17 December 2013 56
3.2.18 September 2013 57
3.2.19 August 2013 58
3.2.20 June 2013 58
3.2.21 March 2013 59
3.2.22 February 2013 60
3.2.23 December 2012 60
3.2.24 August 2012 60
3.2.25 June 2012 61
3.2.26 May 2012 62
3.2.27 March 2012 63
3.2.28 February 2012 64
3.2.29 January 2012 64
3.3 CLINICAL TRIALS 68
3.3.1 Dialysis Catheters 69
3.4 PRODUCT PIPELINES 75
3.4.1 Alliance Vascular Devices, LLC 75
3.4.1.1 FreeHand Safety Huber Needle® 75
3.4.2 AngioDynamics 75
3.4.2.1 Celerity™ PICC Tip Confirmation System with Navigation 75
3.4.2.2 Firefly 75
3.4.2.3 BioFlo® PICC Line Extension 76
3.4.2.4 BioFlo® Port Line Extension 76
3.4.2.5 Next Generation BioFlo® PICC 76
3.4.2.6 Next Generation BioFlo® Port 76
3.4.3 Bluegrass Vascular Technologies, Inc. 76
3.4.3.1 Surfacer® Inside-Out™ Access System 76
3.4.4 C.R. Bard 76
3.4.4.1 Chemical-Resistant PICCs 76
3.4.4.2 Novel Advanced Material PICCs 77
3.4.4.3 PowerGlide® Pro Midline 77
3.4.4.4 AccuCath® 77
3.4.4.5 Xenesis™ Acute Hemodialysis Catheter 77
3.4.4.6 Site~Rite® 8 Ultrasound System 77
3.4.5 M. C. Johnson 77
3.4.5.1 PICC Securement Device 77
3.4.6 Nipro Medical 78
3.4.6.1 Shielding Safety Needle 78
3.4.6.2 Safety Syringe 78
3.4.6.3 Safety PIVC 78
3.4.7 Parasol Medical 78
3.4.7.1 Catheter Securement Device 78
3.4.8 PAVmed Inc. 78
3.4.8.1 NextCath™ 78
3.4.9 Phase One Medical 78
3.4.9.1 Goldilocks™ Long Term Hemodialysis Catheter 78
3.4.9.2 Triple-Lumen Symetrex™ Hemodialysis Catheter 79
3.4.10 Prodigy Diabetes Care, LLC. 79
3.4.10.1 Insulin Pen Needles 79
3.4.11 Sharklet Technologies, Inc. 79
3.4.11.1 Sharklet™ Central Venous Catheter 79
3.4.12 Starboard Medical 79
3.4.12.1 Catheter Securement Devices 79
3.4.13 Teleflex Medical 80
3.4.13.1 Arrow® Endurance™ Extended Dwell Peripheral Catheter System 80
3.4.13.2 Tip Confirmation for CVCs, Chronic Hemodialysis Catheters & Ports 80
3.4.14 Vascular Access Technologies, Inc. 80
3.4.14.1 SAFECVAD™ 80
COUNTRY PROFILES 81
4.1 INTRODUCTION 81
4.1.1 Population 81
4.1.2 GDP Per Capita 81
4.1.3 Price Index 81
4.2 GERMANY 82
4.3 FRANCE 83
4.4 UNITED KINGDOM 84
4.5 ITALY 85
4.6 SPAIN 86
4.7 BENELUX 87
4.8 SCANDINAVIA 88
4.9 AUSTRIA 89
4.10 SWITZERLAND 90
4.11 PORTUGAL 91
DIALYSIS CATHETER MARKET 92
5.1 INTRODUCTION 92
5.1.1 Hemodialysis Catheters 92
5.1.2 Acute Hemodialysis Catheters 93
5.1.3 Chronic Hemodialysis Catheters 93
5.1.4 Peritoneal Dialysis 94
5.1.5 AV Fistulae 94
5.1.6 AV Grafts 95
5.2 MARKET OVERVIEW 96
5.3 MARKET ANALYSIS AND FORECAST 100
5.3.1 Total Dialysis Catheter Market 100
5.3.2 Acute Hemodialysis Catheter Market 108
5.3.3 Total Chronic Hemodialysis Catheter Market 116
5.3.3.1 Conventional Chronic Hemodialysis Catheter Market 124
5.3.3.2 Antimicrobial Chronic Hemodialysis Catheter Market 130
5.3.4 Peritoneal Dialysis Catheter Market 137
5.4 DRIVERS AND LIMITERS 140
5.4.1 Market Drivers 140
5.4.2 Market Limiters 140
5.5 COMPETITIVE MARKET SHARE ANALYSIS 142
ABBREVIATIONS 151
APPENDIX: COMPANY PRESS RELEASES 153
Chart 1 1: Vascular Access Device and Accessories Market by Segment, Europe, 2013 – 2023 2
Chart 1 2: Vascular Access Device and Accessories Market Overview, Europe, 2016 & 2023 2
Chart 4 1: Country Profile, Germany, 2016 82
Chart 4 2: Country Profile, France, 2016 83
Chart 4 3: Country Profile, United Kingdom, 2016 84
Chart 4 4: Country Profile, Italy, 2016 85
Chart 4 5: Country Profile, Spain, 2016 86
Chart 4 6: Country Profile, Benelux, 2016 87
Chart 4 7: Country Profile, Scandinavia, 2016 88
Chart 4 8: Country Profile, Austria, 2016 89
Chart 4 9: Country Profile, Switzerland, 2016 90
Chart 4 10: Country Profile, Portugal, 2016 91
Chart 5 1: Dialysis Catheter Market by Segment, Europe, 2013 – 2023 98
Chart 5 2: Dialysis Catheter Market Breakdown, Europe, 2016 99
Chart 5 3: Dialysis Catheter Market Breakdown, Europe, 2023 99
Chart 5 4: Total Dialysis Catheter Market, Europe, 2013 – 2023 102
Chart 5 5: Acute Hemodialysis Catheter Market, Europe, 2013 – 2023 110
Chart 5 6: Total Chronic Hemodialysis Catheter Market, Europe, 2013 – 2023 118
Chart 5 7: Peritoneal Dialysis Catheter Market, Europe, 2013 – 2023 139
Chart 5 8: Leading Competitors, Total Dialysis Catheter Market, Europe, 2016 147
Figure 1 1: Vascular Access Device and Accessories Competitor Market Share Ranking by Segment, Europe, 2016 (1 of 2) 3
Figure 1 2: Vascular Access Device and Accessories Competitor Market Share Ranking by Segment, Europe, 2016 (2 of 2) 3
Figure 1 3: Companies Researched in this Report, Europe, 2016 4
Figure 1 4: Factors Impacting the Vascular Access Device and Accessories Market by Segment, Europe, 2016 5
Figure 1 5: Recent Events in the Vascular Access Device and Accessories Market, Europe, 2013 – 2016 6
Figure 1 6: Vascular Access Procedures Covered, Europe, 2016 7
Figure 1 7: Vascular Access Device and Accessories Markets Covered, Europe, 2016 (1 of 3) 8
Figure 1 8: Vascular Access Device and Accessories Markets Covered, Europe, 2016 (2 of 3) 9
Figure 1 9: Vascular Access Device and Accessories Markets Covered, Europe, 2016 (3 of 3) 10
Figure 1 10: Key Report Updates 11
Figure 1 11: Version History 12
Figure 3 1: Class 2 Device Recall Medtronic 42
Figure 3 2: Class 2 Device Recall Smiths Medical 42
Figure 3 3: Class 2 Device Recall Arrow 43
Figure 3 4: Class 2 Device Recall Arrow 43
Figure 3 5: Class 2 Device Recall Covidien (Medtronic) 44
Figure 3 6: Class 2 Device Recall Arrow 45
Figure 3 7: Class 2 Device Recall Medline 45
Figure 3 8: Class 2 Device Recall Arrow 45
Figure 3 9: Class 2 Device Recall B. Braun 45
Figure 3 10: Class 3 Device Recall Bard Access 46
Figure 3 11: Class 2 Device Recall Covidien (Medtronic) 46
Figure 3 12: Class 2 Device Recall Bard Access 48
Figure 3 13: Class 2 Device Recall Bard Access 48
Figure 3 14: Class 2 Device Recall Medcomp & AngioDynamics 49
Figure 3 15: Class 2 Device Recall Bard Access 49
Figure 3 16: Class 2 Device Recall Arrow 50
Figure 3 17: Class 2 Device Recall Medcomp 50
Figure 3 18: Class 2 Device Recall Arrow 50
Figure 3 19: Class 2 Device Recall Arrow 51
Figure 3 20: Class 2 Device Recall Smiths Medical 51
Figure 3 21: Class 2 Device Recall PFM Medical 51
Figure 3 22: Class 2 Device Recall PFM Medical 51
Figure 3 23: Class 2 Device Recall Becton Dickinson 52
Figure 3 24: Class 2 Device Recall Arrow 52
Figure 3 25: Class 2 Device Recall Arrow 52
Figure 3 26: Class 2 Device Recall Navilyst Medical 52
Figure 3 27: Class 2 Device Recall Argon Medical 53
Figure 3 28: Class 2 Device Recall Arrow 54
Figure 3 29: Class 2 Device Recall Arrow 54
Figure 3 30: Class 2 Device Recall Arrow 55
Figure 3 31: Class 2 Device Recall Bard Access 55
Figure 3 32: Class 2 Device Recall Navilyst Medical 55
Figure 3 33: Class 2 Device Recall Bard Access 56
Figure 3 34: Class 2 Device Recall Smiths Medical 56
Figure 3 35: Class 2 Device Recall B. Braun 56
Figure 3 36: Class 2 Device Recall Smiths Medical 57
Figure 3 37: Class 2 Device Recall Access Scientific 57
Figure 3 38: Class 2 Device Recall Covidien (Medtronic) 57
Figure 3 39: Class 2 Device Recall Arrow 58
Figure 3 40: Class 2 Device Recall Bard Access 58
Figure 3 41: Class 2 Device Recall Becton Dickinson 58
Figure 3 42: Class 2 Device Recall Churchill Medical Systems, Inc. A Vygon Company 59
Figure 3 43: Class 2 Device Recall Bard Access 59
Figure 3 44: Class 2 Device Recall Churchill Medical Systems, Inc. A Vygon Company 59
Figure 3 45: Class 2 Device Recall Medcomp 60
Figure 3 46: Class 2 Device Recall Becton Dickinson 60
Figure 3 47: Class 3 Device Recall Bard Access 60
Figure 3 48: Class 2 Device Recall Medcomp 61
Figure 3 49: Class 1 Device Recall Arrow 61
Figure 3 50: Class 2 Device Recall Arrow 61
Figure 3 51: Class 2 Device Recall Vygon 61
Figure 3 52: Class 2 Device Recall Covidien (Medtronic) 62
Figure 3 53: Class 2 Device Recall Medcomp 63
Figure 3 54: Class 2 Device Recall Churchill Medical Systems, Inc. A Vygon Company 63
Figure 3 55: Class 2 Device Recall Christie Medical Holdings 63
Figure 3 56: Class 3 Recall Bard Access 63
Figure 3 57: Class 2 Device Recall AngioDynamics 64
Figure 3 58: Class 2 Device Recall Becton Dickinson 64
Figure 3 59: Class 2 Device Recall AngioDynamics 64
Figure 3 60: Class 2 Device Recall AngioDynamics 66
Figure 3 61: Class 3 Device Recall AngioDynamics 67
Figure 3 62: Class 2 Device Recall AngioDynamics 67
Figure 3 63: ACCESS HD Pilot 69
Figure 3 64: Randomized Controlled Trial of Straight Versus Coiled Peritoneal Dialysis 70
Figure 3 65: Randomized Trial Comparing VectorFlow™ Tunneled Dialysis Catheter 70
Figure 3 66: Duration and Adverse Events of Non-cuffed Catheter 70
Figure 3 67: Vascular Access Choice and Outcomes in the Elderly and Very Elderly 71
Figure 3 68: Prevention of Tunneled Cuffed Catheter Malfunction 71
Figure 3 69: Analysis of CRBSI 72
Figure 3 70: A Prospective Multicenter Investigation 72
Figure 3 71: Comparison of an Intensive Versus a Standard Hemodialysis Central Venous Catheter 72
Figure 3 72: Post Marketing Surveillance of the CentrosFLO™ Tunneled IJ Catheter for Dialysis 73
Figure 3 73: Comparison of Self-locating Catheter Versus a Straight Catheter for Outflow Problems 73
Figure 3 74: Multi-Center, Prospective, Randomized, Open-Label, Sponsor-Blinded, Active-Control (Heparin) Clinical Investigation 74
Figure 3 75: Comparative Effectiveness of 30% Trisodium Citrate and Heparin Lock Solutions 74
Figure 5 1: Dialysis Catheter Market by Segment, Europe, 2013 – 2023 (€M) 97
Figure 5 2: Dialysis Catheter Market by Segment, Europe, 2013 – 2023 (US$M) 97
Figure 5 3: Total Dialysis Catheter Market, Europe, 2013 – 2023 (€ and US$) 101
Figure 5 4: Units Sold by Country, Total Dialysis Catheter Market, Europe, 2013-2023 103
Figure 5 5: Average Sales Price by Country, Total Dialysis Catheter Market, Europe, 2013-2023 (€) 104
Figure 5 6: Average Sales Price by Country, Total Dialysis Catheter Market, Europe, 2013-2023 (US$) 105
Figure 5 7: Total Dialysis Catheter Market by Country, Europe, 2013-2023 (€M) 106
Figure 5 8: Total Dialysis Catheter Market by Country, Europe, 2013-2023 (US$M) 107
Figure 5 9: Acute Hemodialysis Catheter Market, Europe, 2013 – 2023 (€ and US$) 109
Figure 5 10: Units Sold by Country, Acute Hemodialysis Catheter Market, Europe, 2013-2023 111
Figure 5 11: Average Sales Price by Country, Acute Hemodialysis Catheter Market, Europe, 2013-2023 (€) 112
Figure 5 12: Average Sales Price by Country, Acute Hemodialysis Catheter Market, Europe, 2013-2023 (US$) 113
Figure 5 13: Acute Hemodialysis Catheter Market by Country, Europe, 2013-2023 (€M) 114
Figure 5 14: Acute Hemodialysis Catheter Market by Country, Europe, 2013-2023 (US$M) 115
Figure 5 15: Total Chronic Hemodialysis Catheter Market, Europe, 2013 – 2023 (€ and US$) 117
Figure 5 16: Units Sold by Country, Total Chronic Hemodialysis Catheter Market, Europe, 2013-2023 119
Figure 5 17: Average Sales Price by Country, Total Chronic Hemodialysis Catheter Market, Europe, 2013-2023 (€) 120
Figure 5 18: Average Sales Price by Country, Total Chronic Hemodialysis Catheter Market, Europe, 2013-2023 (US$) 121
Figure 5 19: Total Chronic Hemodialysis Catheter Market by Country, Europe, 2013-2023 (€M) 122
Figure 5 20: Total Chronic Hemodialysis Catheter Market by Country, Europe, 2013-2023 (US$M) 123
Figure 5 21: Conventional Chronic Hemodialysis Catheter Market, Europe, 2013 – 2023 (€ and US$) 124
Figure 5 22: Units Sold by Country, Conventional Chronic Hemodialysis Catheter Market, Europe, 2013-2023 125
Figure 5 23: Average Sales Price by Country, Conventional Chronic Hemodialysis Catheter Market, Europe, 2013-2023 (€) 126
Figure 5 24: Average Sales Price by Country, Conventional Chronic Hemodialysis Catheter Market, Europe, 2013-2023 (US$) 127
Figure 5 25: Conventional Chronic Hemodialysis Catheter Market by Country, Europe, 2013-2023 (€M) 128
Figure 5 26: Conventional Chronic Hemodialysis Catheter Market by Country, Europe, 2013-2023 (US$M) 129
Figure 5 27: Antimicrobial Chronic Hemodialysis Catheter Market, Europe, 2013 – 2023 (€ and US$) 131
Figure 5 28: Units Sold by Country, Antimicrobial Chronic Hemodialysis Catheter Market, Europe, 2013-2023 132
Figure 5 29: Average Sales Price by Country, Antimicrobial Chronic Hemodialysis Catheter Market, Europe, 2013-2023 (€) 133
Figure 5 30: Average Sales Price by Country, Antimicrobial Chronic Hemodialysis Catheter Market, Europe, 2013-2023 (US$) 134
Figure 5 31: Antimicrobial Chronic Hemodialysis Catheter Market by Country, Europe, 2013-2023 (€M) 135
Figure 5 32: Antimicrobial Chronic Hemodialysis Catheter Market by Country, Europe, 2013-2023 (US$M) 136
Figure 5 33: Peritoneal Dialysis Catheter Market, Europe, 2013 – 2023 (€ and US$) 138
Figure 5 34: Drivers and Limiters, Hemodialysis Catheter Market, Europe, 2016 141
Figure 5 35: Leading Competitors by Country, Total Dialysis Catheter Market, Europe, 2016 146
Figure 5 36: Leading Competitors by Country, Acute Hemodialysis Catheter Market, Europe, 2016 148
Figure 5 37: Leading Competitors by Country, Chronic Hemodialysis Catheter Market, Europe, 2016 149
Figure 5 38: Leading Competitors, Peritoneal Dialysis Catheter Market, Europe, 2016 150
Figure 7 1: Press Release Summary 153
3DT Holdings LLC
3M
Access Scientific
Ambu Inc.
AngioDynamics
Artsana
B. Braun
Baxter International
Becton Dickinson
Bionic
C. R. Bard
Cardinal Health
CareFusion
Codan
Cook Medical
Covidien
Deltamed
Districlass Medical
Edwards Lifesciences
Endeavor Capital
Fresenius
Grupo Sendal
Interrad Medical
Investindustrial
Ivera Medical Corporation
Joline
Kimal
LPI
Medcomp
Medikit
Medtronic
Navilyst Medical
Nipro Medical
Nostix, LLC
Novico
Pentaferte
Perouse Medical
PFM Medical
PFM Medical
PositiveID Corp.
Rays
Romedex
Roundtable Healthcare
Safety Syringes Inc.
Semprus BioSciences
Smiths Medical
SonoSite, Inc.
Teleflex Medical
Terumo
Troge
Vascular Pathways, Inc.
VeriTeQ Acquisition Corp.
VigMed
V-Tech
Vygon
