Aortic Stent Grafts

33 devices 14 with evidence

Clinical Overview

Endovascular stent grafts for aortic aneurysm repair (EVAR/TEVAR).

Procedures that use aortic stent grafts

Endovascular Aneurysm Repair (EVAR)

Aortic Stent Grafts (EVAR/TEVAR) by manufacturer

47 product lines from 9 manufacturers registered with the FDA. Sizes are as listed in the FDA device identification database; confirm with the manufacturer's instructions for use.

Manufacturer	Product	Sizes (FDA GUDID)	Models	MRI
Bolton Medical Inc.	RelayPro Thoracic Stent-Graft System Endovascular Stent-Graft System Suggest edits	Outer Diameter: 22–46 mm; Catheter Gauge: 19–23 Fr; Length: 90–271 mm	2247	MR Conditional
Lombard Medical Limited	Aorfix AAA Stent Graft Body with Aorflex Delivery System Aorflex AAA Stent Graft Body with Aorflex Delivery System FDA record Suggest edits	—	602	MR Conditional
William Cook Europe ApS	Zenith Alpha Zenith Alpha 2, Thoracic Endovascular Graft Distal Extension FDA record Suggest edits	—	204	MR Conditional
Bolton Medical Inc.	RelayPro NBS Thoracic Stent-Graft System Endovascular Stent-Graft System Suggest edits	Outer Diameter: 22–40 mm; Length: 90–259 mm; Catheter Gauge: 19–22 Fr	141	MR Conditional
Cook Incorporated	Zenith Flex Zenith Flex, AAA Main Body Graft Suggest edits	—	140	MR Conditional
Endologix LLC	AFX Endovascular AAA System Suggest edits	—	127	MR Conditional
Medtronic, Inc.	VALIANT Captivia STENT GRAFT VAMC4444C200TU VALCAP CLOSE Suggest edits	—	105	MR Conditional
Cook Incorporated	Zenith Renu Zenith Renu, AAA Ancillary Graft Converter Suggest edits	—	97	MR Conditional
William a. Cook Australia Pty. Ltd.	Zenith Zenith Fenestrated, AAA Endovascular Graft, Distal Body FDA record Suggest edits	—	93	MR Conditional
Medtronic, Inc.	Endurant II STENT GRAFT ETLW1610C124E ENDUR II LIMB FDA record Suggest edits	—	87	MR Conditional
Bolton Medical Inc.	TREO Abdominal Stent-Graft System Endovascular Stent-Graft System Suggest edits	Outer Diameter: 9–36 mm; Length: 40–163 mm; Catheter Gauge: 13–19 Fr	86	MR Conditional
W. L. Gore & Associates, Inc.	GORE EXCLUDER AAA Endoprosthesis EXCLUDER AAA ENDO CONTRA LEG 16mmX27mmX10cm 15Fr FDA record Suggest edits	Outer Diameter: 10–36 mm; Length: 3.3–18 cm; Lumen/Inner Diameter: 10–16 mm	86	MR Conditional
Bolton Medical Inc.	Relay Plus Thoracic Stent-Graft System Endovascular stent-graft system Suggest edits	Outer Diameter: 22–46 mm; Length: 90–250 mm; Catheter Gauge: 22–26 Fr	84	MR Conditional
Bolton Medical Inc.	Relay Thoracic Stent-Graft with Plus Delivery System Endovascular stent-graft system Suggest edits	Outer Diameter: 22–46 mm; Catheter Gauge: 22–26 Fr; Length: 90–250 mm	82	MR Conditional
Endologix LLC	AFX2 Bifurcated Endograft System Suggest edits	—	81	MR Conditional
Medtronic, Inc.	Valiant Navion STENT GRAFT VNMF4343C103TU VAL NAV FF Suggest edits	—	76	MR Conditional
Cook Incorporated	Zenith Zenith, AAA Endovascular Graft Iliac Leg Extension Suggest edits	—	76	MR Conditional
William Cook Europe ApS	Zenith TX2 Pro-Form Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Component FDA record Suggest edits	—	70	MR Conditional
William Cook Europe ApS	Cook Zenith TX2, Dissection Endovascular Graft with Pro-form, and the Z-Trak Plus Introduction System-Straight Component FDA record Suggest edits	—	60	MR Conditional
Medtronic, Inc.	Endurant STENT GRAFT ENTF2828C70E ENDURANT TUBE FDA record Suggest edits	—	58	MR Conditional
W. L. Gore & Associates, Inc.	GORE EXCLUDER AAA Endoprosthesis with C3 Delivery FDA record Suggest edits	Outer Diameter: 12–35 mm; Length: 12–18 cm; Height: 0.5 mm	55	MR Conditional
W. L. Gore & Associates, Inc.	GORE TAG Thoracic Branch Endoprosthesis TAG TBE AORTIC COMPONENT TAG TBE AC 8MMX45MMX15CM Suggest edits	Lumen/Inner Diameter: 8–45 mm; Length: 3.59–24 cm; Catheter Gauge: 14–26 Fr	47	MR Conditional
Endologix LLC	Ovation iX Iliac Stent Graft The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™… Suggest edits	Outer Diameter: 3.96–28 mm; Stent Diameter: 10–28 mm; Catheter Gauge: 12–60 Fr	44	MR Conditional
Lombard Medical Limited	Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System FDA record Suggest edits	—	42	MR Conditional
Cook Incorporated	Zenith Spiral-Z Zenith, Spiral-Z AAA Iliac Leg Suggest edits	—	30	MR Conditional
W. L. Gore & Associates, Inc.	GORE TAG Conformable Thoracic Stent Graft CTAG CMDS 37MMX37MMX15CM 22Fr Suggest edits	Length: 10–20 cm; Outer Diameter: 21–45 mm; Catheter Gauge: 20–24 Fr	25	MR Conditional
W. L. Gore & Associates, Inc.	GORE TAG Conformable Thoracic Endoprosthesis TAG THORACIC ENDO CONFORM 37mmX10cm 24Fr Suggest edits	Outer Diameter: 21–45 mm; Length: 10–20 cm	20	MR Conditional
Endologix LLC	Vela Proximal Endograft System Suggest edits	—	20	MR Conditional
W. L. Gore & Associates, Inc.	GORE TAG Thoracic Endoprosthesis THORACIC ENDOPROSTHESIS TAG 37MMX10CM TOMO Suggest edits	Outer Diameter: 26–45 mm; Length: 10–20 cm	17	MR Conditional
Medtronic, Inc.	Talent Abdominal STENT GRAFT AF2612C155XH BIFURTALENT AAA FDA record Suggest edits	—	15	MR Conditional
Lombard Medical Limited	Aorfix AAA Stent Graft Distal Extender with Aorflex Delivery System FDA record Suggest edits	—	12	MR Conditional
W. L. Gore & Associates, Inc.	GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral EXCLUDER CONFORM AAA TRNK ENDO 28.5mmX12mmX12cm 16Fr FDA record Suggest edits	Lumen/Inner Diameter: 20–36 mm; Length: 12–14 cm; Catheter Gauge: 15–18 Fr	10	MR Conditional
Medtronic, Inc.	Talent Occluder STENT GRAFT OCL10US 10MM OCCLUDER FDA record Suggest edits	Length: 31–35 mm	9	MR Conditional
William a. Cook Australia Pty. Ltd.	Cook Zenith Iliac Branch FDA record Suggest edits	—	8	MR Conditional
Lombard Medical Limited	Aorfix AAA Stent Graft Proximal Extender with Aorflex Delivery System FDA record Suggest edits	—	8	MR Conditional
W. L. Gore & Associates, Inc.	GORE EXCLUDER Conf AAA Endo - Aortic Extender EXCLUDER CONFORM AAA EXT ENDO 26mmX4.5cm 15Fr FDA record Suggest edits	Lumen/Inner Diameter: 20–36 mm; Length: 4.5 cm; Catheter Gauge: 15–18 Fr	6	MR Conditional
W. L. Gore & Associates, Inc.	GORE EXCLUDER Iliac Branch Endoprosthesis EXCLUDER ILIAC BRANCH ENDO 23mmX14.5mmX10cm 16Fr FDA record Suggest edits	Lumen/Inner Diameter: 10–23 mm; Catheter Gauge: 12–16 Fr; Length: 7–10 cm	6	MR Conditional
Endologix LLC	Alto Abdominal Stent Graft System "The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile catheter to treat abdominal aortic aneurysms (AAAs). The… Suggest edits	Stent Diameter: 20–34 mm; Catheter Working Length: 60 cm; Outer Diameter: 5.13 mm	5	MR Conditional
Trivascular, Inc.	Ovation Prime Abdominal Stent Graft System The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic… Suggest edits	Outer Diameter: 10–34 mm; Catheter Gauge: 13–15 Fr; Length: 45–140 mm	5	MR Conditional
Medtronic, Inc.	Endurant IIs STENT GRAFT ESBF3214C103E ENDUR IIS BIF FDA record Suggest edits	—	5	MR Conditional
Lombard Medical Limited	Aorfix AAA Stent Graft Converter with Aorflex Delivery System FDA record Suggest edits	—	4	MR Conditional
Endologix LLC	Ovation Prime Abdominal Stent Graft System The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic… Suggest edits	Total Volume: 14 mL	1	MR Conditional
Trivascular, Inc.	Ovation iX Abdominal Stent Graft System The TriVascular® Ovation iX™ Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal stent… Suggest edits	Outer Diameter: 20–34 mm; Catheter Gauge: 14–15 Fr	1	MR Conditional
Trivascular, Inc.	Ovation Prime Abominal Stent Graft System The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic… Suggest edits	Outer Diameter: 12–14 mm; Catheter Gauge: 13 Fr; Length: 120 mm	1	MR Conditional
Trivascular, Inc.	Ovation Prime Adominal Stent Graft System The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic… Suggest edits	Catheter Gauge: 14 Fr; Outer Diameter: 26 mm	1	MR Conditional
Endologix LLC	Autoinjector 2 "The Autoinjector 2 is a component of the Alto™ Abdominal Stent Graft System. The Autoinjector 2 applies controlled force to the syringe… Suggest edits	—	1	MR Conditional
Endologix LLC	CustomSeal Kit The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile catheter to treat abdominal aortic aneurysms (AAAs). The… Suggest edits	Total Volume: 14 mL	1	MR Conditional

All Manufacturers Apollo Spine Cadwell Industries Cook Cook Medical Foremost Dental Mfg. Inneuro Jeneric Ind. Lombard Medical Medtronic Endovascular Innovations Medtronic Vascular Ortho Tec Orthopaedic Innovations Qxmedical Remed Tgm Medical Via Biomedical W. L. Gore And Associates W.L. Gore & Associates William Cook Europe Aps Williams Manufacturing All Pathways 510K PMA Any Evidence Level 1+ Studies 2+ Studies 5+ Studies 10+ Studies Filter Clear Filters

Device	Manufacturer	Pathway	Cleared	Evidence
Gore Excluder Aaa Endoprosthesis Evidence	W.L. Gore & Associates	PMA	2006	40
Gore Excluder Thoracoabdominal Branch Endoprosthesis Evidence	W.L. Gore & Associates	PMA	2024	40
Gore Excluder Conformable Aaa Endoprosthesis Excc Evidence	W. L. Gore And Associates	PMA	2023	40
Zenith Traveler Chiropractic Table	Williams Manufacturing	510(k)	1988	35
Zenith 40 Phosphoric Acid Gel	Foremost Dental Mfg.	510(k)	1989	35
Zenith Evidence	Jeneric Ind.	510(k)	1983	35
Zenith Luxacore Automix Core Material Multiple	Foremost Dental Mfg.	510(k)	1998	35
Zenith Plate System Anterior Spinal Instrumentation	Ortho Tec	510(k)	2001	35
046 Zenith Flex	Inneuro	510(k)	2019	35
Zenith Cox Flexion Chiropractic Table	Williams Manufacturing	510(k)	1991	35
065 Zenith 074 Zenith	Inneuro	510(k)	2017	35
Zenith TX2 Thoracic Taa Endovascular Graft with the H Lb One-Shot Introduction System Evidence	William Cook Europe Aps	PMA	2008	35
Zenith Dissection Endovascular System Evidence	William Cook Europe Aps	PMA	2024	35
Zenith Support 95 Cm Zenith Support 105 Cm Zenith Support 115 Cm Evidence	Inneuro	510(k)	2018	35
Cadwell Zenith System	Cadwell Industries	510(k)	2018	35
Oria Zenith Evidence	Ortho Tec	510(k)	2003	35
Zenith Flex System Evidence	Inneuro	510(k)	2018	35
Zenith R Fenestrated Aaa Endovascular Graft Zenith R Flex Aaa Endovascular System Evidence	Cook	PMA	2023	35
Zenith R Alpha Thoracic Endovascular Graft	Cook Medical	PMA	2024	35
Zenith Pedicle System Evidence	Apollo Spine	510(k)	2011	35
Zenith Femoral Stem Zenith Distal Centralizer Fomoral Head Acetabular Insert	Tgm Medical	510(k)	2012	35
Zenith Total Etch 10 Phosphoric Acid	Foremost Dental Mfg.	510(k)	1994	35
Zenith Hylo and Verti-Lift Chiropractic Tables	Williams Manufacturing	510(k)	1990	35
074 Zenith Flex System	Inneuro	510(k)	2018	35
Endurant and Endurant II Stent Graft System Evidence	Medtronic Vascular	PMA	2014	15
Orthopaedic Innovations Renewal Acetabular Cup System	Orthopaedic Innovations	510(k)	2002	10
Talent-Pro Electromagnetic Stimulator	Remed	510(k)	2021	—
Talent Occluder W Occluder Delivery System	Medtronic Vascular	PMA	2016	—
Reliant Stent Graft Balloon Catheter	Medtronic Endovascular Innovations	510(k)	2005	—
Talent Thoracic Stent Graft System with the Xcelerant and Captiva Delivery System Evidence	Medtronic Vascular	PMA	2012	—
Aorfix Aa Flexible Stent Graft System	Lombard Medical	PMA	2013	—
Stent Graft Balloon Catheter Evidence	Via Biomedical	510(k)	2009	—
Q50 Plus Stent Graft Balloon Catheter	Qxmedical	510(k)	2012	—