Aortic Stent Grafts - Medical Devices Pipeline Assessment, 2015

SKU ID :GD-10078225 | Published Date: 01-Jan-2016 | No. of pages: 195
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 GlobalData 194 7.3 Contact Us 195 7.4 Disclaimer 195
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 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
Aptus Endosystems, Inc. BiFlow Medical Ltd BioQ Devices Pty Ltd Bolton Medical, Inc. Cardiatis SA Cardiovate Clinique du Coeur et des Vaisseaux Cook Medical Incorporated Cordis Corporation Cytograft Tissue Engineering, Inc. Endologix, Inc. Endoluminal Sciences Pty Ltd. EndoSpan Ltd Evasc Medical Systems Innovia LLC Lifetech Scientific (Shenzhen) Co., Ltd. LimFlow GmbH Lombard Medical Technologies Inc. Lombard Medical Technologies Plc Medtronic plc MicroPort Scientific Corporation St. Jude Medical, Inc. Terumo Corporation Transcatheter Technologies GmbH TriVascular, Inc. University of California, San Diego University of Limerick University of Rochester W. L. Gore & Associates, Inc.
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