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Aortic Stent Grafts - Medical Devices Pipeline Assessment, 2015

  • ID:RM00343093
  • Published: January-2016
  • Pages:195
  • GlobalData
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Aortic Stent Grafts - Medical Devices Pipeline Assessment, 2015

Summary

The author's Medical Devices sector report, Aortic Stent Grafts - Medical Devices Pipeline Assessment, 2015" provides an overview of Aortic Stent Grafts currently in pipeline stage.

The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Aortic Stent Grafts pipeline products.

This report is prepared using data sourced from in-house databases, secondary and primary research by The........
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1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 9
2 Introduction 10
2.1 Aortic Stent Grafts Overview 10
3 Products under Development 11
3.1 Aortic Stent Grafts - Pipeline Products by Stage of Development 11
3.2 Aortic Stent Grafts - Pipeline Products by Segment 12
3.3 Aortic Stent Grafts - Pipeline Products by Territory 13
3.4 Aortic Stent Grafts - Pipeline Products by Regulatory Path 14
3.5 Aortic Stent Grafts - Pipeline Products by Estimated Approval Date 15
3.6 Aortic Stent Grafts - Ongoing Clinical Trials 16
4 Aortic Stent Grafts - Pipeline Products under Development by Companies 17
4.1 Aortic Stent Grafts Companies - Pipeline Products by Stage of Development 17
4.2 Aortic Stent Grafts - Pipeline Products by Stage of Development 19
5 Aortic Stent Grafts Companies and Product Overview 21
5.1 Aptus Endosystems, Inc. Company Overview 21
5.1.1 Aptus Endosystems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 21
5.2 BiFlow Medical Ltd Company Overview 25
5.2.1 BiFlow Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 25
5.3 BioQ Devices Pty Ltd Company Overview 27
5.3.1 BioQ Devices Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 27
5.4 Bolton Medical, Inc. Company Overview 28
5.4.1 Bolton Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 28
5.5 Cardiatis SA Company Overview 35
5.5.1 Cardiatis SA Pipeline Products & Ongoing Clinical Trials Overview 35
5.6 Cardiovate Company Overview 37
5.6.1 Cardiovate Pipeline Products & Ongoing Clinical Trials Overview 37
5.7 Clinique du Coeur et des Vaisseaux Company Overview 38
5.7.1 Clinique du Coeur et des Vaisseaux Pipeline Products & Ongoing Clinical Trials Overview 38
5.8 Cook Medical Incorporated Company Overview 39
5.8.1 Cook Medical Incorporated Pipeline Products & Ongoing Clinical Trials Overview 39
5.9 Cordis Corporation Company Overview 46
5.9.1 Cordis Corporation Pipeline Products & Ongoing Clinical Trials Overview 46
5.10 Cytograft Tissue Engineering, Inc. Company Overview 49
5.10.1 Cytograft Tissue Engineering, Inc. Pipeline Products & Ongoing Clinical Trials Overview 49
5.11 Endologix, Inc. Company Overview 50
5.11.1 Endologix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 50
5.12 Endoluminal Sciences Pty Ltd. Company Overview 69
5.12.1 Endoluminal Sciences Pty Ltd. Pipeline Products & Ongoing Clinical Trials Overview 69
5.13 EndoSpan Ltd Company Overview 70
5.13.1 EndoSpan Ltd Pipeline Products & Ongoing Clinical Trials Overview 70
5.14 Evasc Medical Systems Company Overview 75
5.14.1 Evasc Medical Systems Pipeline Products & Ongoing Clinical Trials Overview 75
5.15 Innovia LLC Company Overview 76
5.15.1 Innovia LLC Pipeline Products & Ongoing Clinical Trials Overview 76
5.16 Lifetech Scientific (Shenzhen) Co., Ltd. Company Overview 77
5.16.1 Lifetech Scientific (Shenzhen) Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 77
5.17 LimFlow GmbH Company Overview 78
5.17.1 LimFlow GmbH Pipeline Products & Ongoing Clinical Trials Overview 78
5.18 Lombard Medical Technologies Inc. Company Overview 79
5.18.1 Lombard Medical Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 79
5.19 Lombard Medical Technologies Plc Company Overview 82
5.19.1 Lombard Medical Technologies Plc Pipeline Products & Ongoing Clinical Trials Overview 82
5.20 Medtronic plc Company Overview 83
5.20.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 83
5.21 MicroPort Scientific Corporation Company Overview 91
5.21.1 MicroPort Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 91
5.22 St. Jude Medical, Inc. Company Overview 96
5.22.1 St. Jude Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 96
5.23 Terumo Corporation Company Overview 100
5.23.1 Terumo Corporation Pipeline Products & Ongoing Clinical Trials Overview 100
5.24 Transcatheter Technologies GmbH Company Overview 102
5.24.1 Transcatheter Technologies GmbH Pipeline Products & Ongoing Clinical Trials Overview 102
5.25 TriVascular, Inc. Company Overview 103
5.25.1 TriVascular, Inc. Pipeline Products & Ongoing Clinical Trials Overview 103
5.26 University of California, San Diego Company Overview 107
5.26.1 University of California, San Diego Pipeline Products & Ongoing Clinical Trials Overview 107
5.27 University of Limerick Company Overview 108
5.27.1 University of Limerick Pipeline Products & Ongoing Clinical Trials Overview 108
5.28 University of Rochester Company Overview 109
5.28.1 University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 109
5.29 W. L. Gore & Associates, Inc. Company Overview 110
5.29.1 W. L. Gore & Associates, Inc. Pipeline Products & Ongoing Clinical Trials Overview 110
6 Aortic Stent Grafts- Recent Developments 116
7 Appendix 192
7.1 Methodology 192
7.2 About The author 194
7.3 Contact Us 195
7.4 Disclaimer 195


List Of Tables

1.1 List of Tables
Table 1: Aortic Stent Grafts - Pipeline Products by Stage of Development 11
Table 2: Aortic Stent Grafts - Pipeline Products by Segment 12
Table 3: Aortic Stent Grafts - Pipeline Products by Territory 13
Table 4: Aortic Stent Grafts - Pipeline Products by Regulatory Path 14
Table 5: Aortic Stent Grafts - Pipeline Products by Estimated Approval Date 15
Table 6: Aortic Stent Grafts - Ongoing Clinical Trials 16
Table 7: Aortic Stent Grafts Companies - Pipeline Products by Stage of Development 17
Table 8: Aortic Stent Grafts - Pipeline Products by Stage of Development 19
Table 9: Aptus Endosystems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 21
Table 10: Fortevo AAA Endograft System - Product Status 22
Table 11: Fortevo AAA Endograft System - Product Description 22
Table 12: Aptus Endosystems, Inc. - Ongoing Clinical Trials Overview 23
Table 13: Fortevo AAA Endograft System - The Pivotal Study Of The Aptus Endovascular AAA Repair System 24
Table 14: BiFlow Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 25
Table 15: Stainless Steel Nitinol Two-Way Shape Memory Stent - Product Status 26
Table 16: Stainless Steel Nitinol Two-Way Shape Memory Stent - Product Description 26
Table 17: BioQ Devices Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 27
Table 18: BioQ Aortic Stent Graft Assist - Product Status 27
Table 19: BioQ Aortic Stent Graft Assist - Product Description 27
Table 20: Bolton Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 28
Table 21: Relay Abdominal Stent Graft - Product Status 29
Table 22: Relay Abdominal Stent Graft - Product Description 29
Table 23: Relay NBS Abdominal Stent Graft - Product Status 30
Table 24: Relay NBS Abdominal Stent Graft - Product Description 30
Table 25: RELAY NBS Thoracic Stent-Graft - Product Status 31
Table 26: RELAY NBS Thoracic Stent-Graft - Product Description 31
Table 27: Treovance Abdominal Stent Graft With Navitel Delivery System - Product Status 32
Table 28: Treovance Abdominal Stent Graft With Navitel Delivery System - Product Description 32
Table 29: Bolton Medical, Inc. - Ongoing Clinical Trials Overview 33
Table 30: Treovance Abdominal Stent Graft With Navitel Delivery System - A Phase II Clinical Study of the Safety and Performance of the Treovance Stent-graft with Navitel Delivery System for Patients with Infrarenal Abdominal Aortic Aneurysms 34
Table 31: Cardiatis SA Pipeline Products & Ongoing Clinical Trials Overview 35
Table 32: Cardiatis C5 - Product Status 36
Table 33: Cardiatis C5 - Product Description 36
Table 34: Cardiovate Pipeline Products & Ongoing Clinical Trials Overview 37
Table 35: TESAR Stent-Graft - Product Status 37
Table 36: TESAR Stent-Graft - Product Description 37
Table 37: Clinique du Coeur et des Vaisseaux Pipeline Products & Ongoing Clinical Trials Overview 38
Table 38: Multilayer Flow Modulator - Product Status 38
Table 39: Multilayer Flow Modulator - Product Description 38
Table 40: Cook Medical Incorporated Pipeline Products & Ongoing Clinical Trials Overview 39
Table 41: Zenith Helical Branch Iliac Endovascular Graft - Product Status 40
Table 42: Zenith Helical Branch Iliac Endovascular Graft - Product Description 40
Table 43: Zenith Low Profile Abdominal Aortic Aneurysm Endovascular Graft - Product Status 41
Table 44: Zenith Low Profile Abdominal Aortic Aneurysm Endovascular Graft - Product Description 41
Table 45: Zenith TX2 LP TAA Endovascular Graft - Product Status 42
Table 46: Zenith TX2 LP TAA Endovascular Graft - Product Description 42
Table 47: Cook Medical Incorporated - Ongoing Clinical Trials Overview 43
Table 48: Zenith Low Profile Abdominal Aortic Aneurysm Endovascular Graft - Clinical Investigation Plan for the Zenith Low Profile AAA Endovascular Graft 44
Table 49: Zenith Low Profile Abdominal Aortic Aneurysm Endovascular Graft - Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients 44
Table 50: Zenith Low Profile Abdominal Aortic Aneurysm Endovascular Graft - Evaluation of the Safety and Effectiveness of the Zenith Low Profile AAA Endovascular Graft 44
Table 51: Zenith TX2 LP TAA Endovascular Graft - Zenith TX2 Low Profile TAA Endovascular Graft Clinical Study 45
Table 52: Cordis Corporation Pipeline Products & Ongoing Clinical Trials Overview 46
Table 53: INCRAFT AAA Stent Graft - Product Status 46
Table 54: INCRAFT AAA Stent Graft - Product Description 46
Table 55: Cordis Corporation - Ongoing Clinical Trials Overview 47
Table 56: INCRAFT AAA Stent Graft - A Multicenter, Open Label, Prospective, Post Approval Study of the INCRAFT Abdominal Aortic Aneurysm (AAA) Stent Graft System in Subjects with Abdominal Aortic Aneurysms 48
Table 57: INCRAFT AAA Stent Graft - Compassionate Use of the Incraft AAA Stent Graft System 48
Table 58: Cytograft Tissue Engineering, Inc. Pipeline Products & Ongoing Clinical Trials Overview 49
Table 59: LifeJacket AAA Stent Graft - Product Status 49
Table 60: LifeJacket AAA Stent Graft - Product Description 49
Table 61: Endologix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 50
Table 62: AFX - Product Status 51
Table 63: AFX - Product Description 51
Table 64: AFX2 Bifurcated Endograft System - Product Status 52
Table 65: AFX2 Bifurcated Endograft System - Product Description 52
Table 66: AFX3 - Product Status 53
Table 67: AFX3 - Product Description 53
Table 68: AFX4 - Product Status 54
Table 69: AFX4 - Product Description 54
Table 70: Angulated Neck Stent Graft - Product Status 55
Table 71: Angulated Neck Stent Graft - Product Description 55
Table 72: Nellix EVAS System - Product Status 56
Table 73: Nellix EVAS System - Product Description 56
Table 74: Nellix With Snorkels - Product Status 57
Table 75: Nellix With Snorkels - Product Description 57
Table 76: Nellix2 AAA Endovascular System - Product Status 58
Table 77: Nellix2 AAA Endovascular System - Product Description 58
Table 78: Paravisceral System - Product Status 59
Table 79: Paravisceral System - Product Description 59
Table 80: Ventana 2 - Product Status 60
Table 81: Ventana 2 - Product Description 60
Table 82: Ventana Fenestrated Stent Graft - Product Status 61
Table 83: Ventana Fenestrated Stent Graft - Product Description 61
Table 84: Xpand BX Covered Stent - Product Status 62
Table 85: Xpand BX Covered Stent - Product Description 62
Table 86: Endologix, Inc. - Ongoing Clinical Trials Overview 63
Table 87: Nellix EVAS System - Aneurysm Study for Complex AAA: Evaluation of Nellix Durability 64
Table 88: Nellix EVAS System - Clinical Relevance of Positron Emission Tomography (PET) Imaging Following Endovascular Aneurysm Repair Using the Nellix Endoprosthesis 64
Table 89: Nellix EVAS System - Multicenter, Observational, Post-Market, Real World Registry to Assess Outcomes of Patients Treated with the Nellix System for Endovascular Abdominal Aortic Aneurysm Repair 64
Table 90: Nellix EVAS System - Post-operative CT Follow up Measurement After Nellix Endoprosthesis Implantation in Patients With Abdominal Aortic Aneurysms 65
Table 91: Nellix EVAS System - Prospective, Multicenter, Single Arm Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System:A Pivotal and Continued Access Study 65
Table 92: Ventana Fenestrated Stent Graft - Pilot Study Of The Ventana Fenestrated Stent Graft As A New Aortic Extension Designed To Be Used With The Anatomically-Fixed Powerlink Bifurcated Stent Graft 66
Table 93: Ventana Fenestrated Stent Graft - Prospective, Multicenter, Single Arm Safety and Effectiveness Trial of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms 66
Table 94: AFX - Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic Aneurysms: An Investigator-Initiated Study 67
Table 95: Nellix2 AAA Endovascular System - Dynamic CT Imaging After Nellix Endoprosthesis Implantation 68
Table 96: Endoluminal Sciences Pty Ltd. Pipeline Products & Ongoing Clinical Trials Overview 69
Table 97: Stent-graft With Adhesive Delivery Platform - Product Status 69
Table 98: Stent-graft With Adhesive Delivery Platform - Product Description 69
Table 99: EndoSpan Ltd Pipeline Products & Ongoing Clinical Trials Overview 70
Table 100: Horizon AAA Repair System - Product Status 70
Table 101: Horizon AAA Repair System - Product Description 70
Table 102: Nexus - Product Status 71
Table 103: Nexus - Product Description 71
Table 104: EndoSpan Ltd - Ongoing Clinical Trials Overview 72
Table 105: Nexus - Feasibility Clinical Study to Evaluate the Safety and Performance of the NEXUS Aortic Arch Stent Graft System 73
Table 106: Horizon AAA Repair System - A Prospective Open-label Non-randomized Pivotal Study to Evaluate the Safety and Performance of the Horizon Abdominal Aortic Aneurysm (AAA) Stent Graft System 74
Table 107: Evasc Medical Systems Pipeline Products & Ongoing Clinical Trials Overview 75
Table 108: TAS System - Product Status 75
Table 109: TAS System - Product Description 75
Table 110: Innovia LLC Pipeline Products & Ongoing Clinical Trials Overview 76
Table 111: Stent Graft With Leg Locking Anchor - Product Status 76
Table 112: Stent Graft With Leg Locking Anchor - Product Description 76
Table 113: Lifetech Scientific (Shenzhen) Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 77
Table 114: Ankura II Stent Graft - Product Status 77
Table 115: Ankura II Stent Graft - Product Description 77
Table 116: LimFlow GmbH Pipeline Products & Ongoing Clinical Trials Overview 78
Table 117: LimFlow Stent Graft System - Product Status 78
Table 118: LimFlow Stent Graft System - Product Description 78
Table 119: Lombard Medical Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 79
Table 120: Altura Endograft System - Product Status 79
Table 121: Altura Endograft System - Product Description 79
Table 122: Lombard Medical Technologies Inc. - Ongoing Clinical Trials Overview 80
Table 123: Altura Endograft System - Kissing Endografts for Peripheral AAA Exclusion (ELEVATEInternational) 81
Table 124: Altura Endograft System - The Altura AAA Endograft Safety and Feasibility Study For Exclusion of Abdominal Aortic Aneurysms 81
Table 125: Lombard Medical Technologies Plc Pipeline Products & Ongoing Clinical Trials Overview 82
Table 126: Low Profile Stent Graft - Product Status 82
Table 127: Low Profile Stent Graft - Product Description 82
Table 128: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 83
Table 129: Endurant Evo AAA Stent Graft System - Product Status 84
Table 130: Endurant Evo AAA Stent Graft System - Product Description 84
Table 131: TAAA Debranching Stent Graft - Product Status 85
Table 132: TAAA Debranching Stent Graft - Product Description 85
Table 133: Valiant EVO - Product Status 86
Table 134: Valiant EVO - Product Description 86
Table 135: Valiant Mona LSA System - Product Status 87
Table 136: Valiant Mona LSA System - Product Description 87
Table 137: Medtronic plc - Ongoing Clinical Trials Overview 88
Table 138: Valiant Mona LSA System - Feasibility Study of Valiant 'Mona LSA' Branch Thoracic Stent Graft System 89
Table 139: Valiant Mona LSA System - Valiant Mona LSA Stent Graft System Early Feasibility Study 89
Table 140: Endurant Evo AAA Stent Graft System - Endurant Evo International Clinical Trial 90
Table 141: Endurant Evo AAA Stent Graft System - Endurant Evo US Clinical Trial 90
Table 142: MicroPort Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview 91
Table 143: Castor Branched Stent Graft System - Product Status 92
Table 144: Castor Branched Stent Graft System - Product Description 92
Table 145: HT-LP - Product Status 93
Table 146: HT-LP - Product Description 93
Table 147: MicroPort Scientific Corporation - Ongoing Clinical Trials Overview 94
Table 148: Castor Branched Stent Graft System - A Multi-center Trial of Castor Single-Branched Stent Graft System for Endovascular Repair of Aortic Dissection 95
Table 149: St. Jude Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 96
Table 150: Amplatzer AAA Vascular Graft - Product Status 97
Table 151: Amplatzer AAA Vascular Graft - Product Description 97
Table 152: Amplatzer Peripheral Vascular Graft - Product Status 98
Table 153: Amplatzer Peripheral Vascular Graft - Product Description 98
Table 154: Amplatzer TAA Vascular Graft - Product Status 99
Table 155: Amplatzer TAA Vascular Graft - Product Description 99
Table 156: Terumo Corporation Pipeline Products & Ongoing Clinical Trials Overview 100
Table 157: Anaconda Endovascular Stent Graft - Product Status 101
Table 158: Anaconda Endovascular Stent Graft - Product Description 101
Table 159: Transcatheter Technologies GmbH Pipeline Products & Ongoing Clinical Trials Overview 102
Table 160: Tumbao EndoVascular Aortic Repair System - Product Status 102
Table 161: Tumbao EndoVascular Aortic Repair System - Product Description 102
Table 162: TriVascular, Inc. Pipeline Products & Ongoing Clinical Trials Overview 103
Table 163: Ovation Alto System - Product Status 104
Table 164: Ovation Alto System - Product Description 104
Table 165: Ovation iX Aortic Body - Product Status 105
Table 166: Ovation iX Aortic Body - Product Description 105
Table 167: Ovation Thoracic Stent Graft System - Product Status 106
Table 168: Ovation Thoracic Stent Graft System - Product Description 106
Table 169: University of California, San Diego Pipeline Products & Ongoing Clinical Trials Overview 107
Table 170: Biliary Endoprosthesis Stent Graft - Product Status 107
Table 171: Biliary Endoprosthesis Stent Graft - Product Description 107
Table 172: University of Limerick Pipeline Products & Ongoing Clinical Trials Overview 108
Table 173: Cardiovascular Graft - Product Status 108
Table 174: Cardiovascular Graft - Product Description 108
Table 175: University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 109
Table 176: Fenestrated Venous Endograft - Product Status 109
Table 177: Fenestrated Venous Endograft - Product Description 109
Table 178: W. L. Gore & Associates, Inc. Pipeline Products & Ongoing Clinical Trials Overview 110
Table 179: GORE EXCLUDER Conformable AAA Endoprosthesis - Product Status 111
Table 180: GORE EXCLUDER Conformable AAA Endoprosthesis - Product Description 111
Table 181: GORE TAG Thoracic Branch Endoprosthesis - Product Status 112
Table 182: GORE TAG Thoracic Branch Endoprosthesis - Product Description 112
Table 183: W. L. Gore & Associates, Inc. - Ongoing Clinical Trials Overview 113
Table 184: GORE TAG Thoracic Branch Endoprosthesis - GORE TAG Thoracic Branch Endoprosthesis Early Feasibility Study 114
Table 185: GORE EXCLUDER Conformable AAA Endoprosthesis - GORE EXCLUDER Conformable AAA Endoprosthesis Study in US and Japan 115
Table 186: Glossary 193


List of Figures

1.2 List of Figures
Figure 1: Aortic Stent Grafts - Pipeline Products by Stage of Development 11
Figure 2: Aortic Stent Grafts - Pipeline Products by Segment 12
Figure 3: Aortic Stent Grafts - Pipeline Products by Territory 13
Figure 4: Aortic Stent Grafts - Pipeline Products by Regulatory Path 14
Figure 5: Aortic Stent Grafts - Pipeline Products by Estimated Approval Date 15
Figure 6: Aortic Stent Grafts - Ongoing Clinical Trials 16

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