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Endurant and Endurant II Stent Graft System
Medtronic Vascular
Product: Endurant II — all models and sizes
Summary: The Endurant and Endurant II stent graft systems are used for endovascular aneurysm repair, primarily in abdominal aortic aneurysms. Key evidence highlights their use both within and outside standard instructions, with studies examining outcomes like limb graft occlusion and thrombus formation.
FDA Clearance Information
Pathway ?
PMA
Number ?
P100021 ↗
Decision Date ?
July 8, 2014
Product Code ?
MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Device Class ?
Class 3
Evidence ?
15 studies
The Endurant and Endurant II stent graft systems received FDA premarket approval (PMA) on July 8, 2014. Manufactured by Medtronic Vascular, they are classified as Class III medical devices.
What It Is
The Endurant and Endurant II stent graft systems are endovascular devices designed for the repair of abdominal aortic aneurysms. They function by providing a scaffold within the aorta to support the vessel wall and exclude the aneurysm from blood flow.
FDA-Cleared Indications
- FDA approval covers introducing a LAMP mandrel as a manufacturing tool for radiopaque contralateral-gate-marker inspection of Endurant and Endurant II bifurcated stent grafts.
- FDA approval covers use of a coil dispenser as a visual aid during the pre-kitting process of Endurant II stent grafts.
Clinical Applications
- Manufacturing inspection of radiopaque contralateral gate markers on Endurant and Endurant II bifurcated stent grafts.
- Pre-kitting visualization of Endurant II stent graft components using a coil dispenser.
- The Endurant product family is clinically used for endovascular repair of abdominal aortic aneurysms under its separate device labeling; the supplied FDA text does not provide those clinical indications.
Reported off-label uses
- Use of abdominal aortic endograft systems in selected patients with anatomy outside the device's labeled instructions for use, including challenging aortic neck or iliac anatomy, has been described in clinical practice and literature. Such use is off-label and requires individualized specialist assessment.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes 15 studies, encompassing retrospective evaluations and multicenter registries, with data collected from 2009 to 2023. These studies assess both the short-term and long-term performance of the stent graft systems.
Reported Outcomes
Published studies report that the Endurant and Endurant II stent graft systems are effective in managing abdominal aortic aneurysms, with outcomes such as reduced limb graft occlusion and intra-prosthetic thrombus formation. Long-term data from Japanese cohorts indicate favorable results compared to other stent grafts.
Safety Profile
Reported complications include limb graft occlusion and intra-prosthetic thrombus formation. These issues were observed in comparative studies with other stent graft systems, highlighting the need for careful patient selection and monitoring.
Evidence Limitations
The evidence is primarily retrospective, with limited prospective randomized controlled trials. Further research is needed to explore long-term outcomes and safety in diverse patient populations, as well as the impact of anatomical variations on device performance.
Practical Considerations
- The supplied FDA indication concerns manufacturing tools, so clinicians should consult the current Endurant or Endurant II instructions for use before selecting or implanting a graft.
- Clinical implantation requires compatible aortic and iliac anatomy, including adequate landing zones, access vessels, and vessel diameters within the manufacturer's labeled ranges.
- The system is delivered through vascular access, commonly from the femoral arteries, under fluoroscopic imaging; sizing and deployment require detailed preprocedure CT angiography.
- MRI safety and conditional scanning limits depend on the exact implanted graft model and current labeling; confirm the specific device's MRI conditions before scanning.
- Important contraindications and precautions can include unsuitable anatomy, severe access-vessel disease, active infection, inability to tolerate contrast or anticoagulation, and inadequate follow-up imaging.
Linked Studies (15)
PubMed • 2024
Endurant Stent Graft for Treatment of Abdominal Aortic Aneurysm Inside and Outside of the Instructions for Use for the Proximal Neck: A 14-Year, Single-Center Experience.
Journal of clinical medicine
View Source →PubMed • 2023
Treatment of Aortoiliac Aneurysms: Compatibility of the E-liac Stent Graft (Artivion®, Iliac Branch Device) with Endurant II or IIs (Medtronic®, EVAR).
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
A Retrospective Evaluation of Intra-Prosthetic Thrombus Formation After Endovascular Aortic Repair in Cook Zenith Alpha and Medtronic Endurant II Patients.
European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery
Retrospective View Source →PubMed • 2023
Long-term Outcomes of the Endurant and Excluder Stent Grafts for Endovascular Aneurysm Repair in a Japanese Cohort.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Outcomes of Endurant II Stent Graft According to Anatomic Severity Grade Score.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2022
Primary Endovascular Treatment of Late-Onset Type 3 Endovascular Aortic Repair Rupture Using The Endurant II Stent Graft and Rapid Response Protocol.
Turk Kardiyoloji Dernegi arsivi : Turk Kardiyoloji Derneginin yayin organidir
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2019
Type II Endoleak After Endovascular Aortic Aneurysm Repair Using the Endurant Stent Graft System for Abdominal Aortic Aneurysm with Occluded Inferior Mesenteric Artery.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2019
Preliminary experience with the Endurant II short form stent-graft system.
The Journal of cardiovascular surgery
Other View Source →PubMed • 2017
Use of Endurant Stent-Graft Aortic Extensions for the Treatment of Focal Aortic Pathology.
Annals of vascular surgery
Other View Source →PubMed • 2017
Cinical outcomes of Endurant II stent-graft for infrarenal aortic aneurysm repair: comparison of on-label versus off-label use.
Diagnostic and interventional radiology (Ankara, Turkey)
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2015
Predictive factors for limb occlusions after endovascular aneurysm repair.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2014
Anatomic suitability for endovascular repair of abdominal aortic aneurysms and possible benefits of low profile delivery systems.
Vascular
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2009
Endurant stent-graft system: preliminary report on an innovative treatment for challenging abdominal aortic aneurysm.
The Journal of cardiovascular surgery
RCT|prospective|retrospective|case Series|other View Source →ClinicalTrials.gov
Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (ENDURANT France)
View Source →Frequently Asked Questions
What are the clinical indications for Endurant and Endurant II stent graft systems?
The devices are indicated for the repair of abdominal aortic aneurysms, particularly in patients unsuitable for open surgical repair.
What outcomes have been reported in clinical studies?
Studies report effective aneurysm exclusion, with outcomes such as reduced limb graft occlusion and intra-prosthetic thrombus formation.
What complications have been reported?
Safety data indicate complications such as limb graft occlusion and intra-prosthetic thrombus formation, necessitating careful patient monitoring.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.