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endurant and endurant ii stent graft system

Medtronic Vascular

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
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.

Clinical Applications

These stent graft systems are commonly used in patients with abdominal aortic aneurysms, particularly when traditional open surgical repair is not feasible. They are also used in cases involving complex aortoiliac aneurysms.

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.

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 for Challenging Anatomy: Global Experience Registry

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.

Related Device Categories

Aortic Stent Grafts
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.

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