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Zenith R Fenestrated Aaa Endovascular Graft Zenith R Flex Aaa Endovascular System
Product: Zenith — all models and sizes
Summary: The Zenith R Fenestrated AAA Endovascular Graft by Cook is designed for abdominal aortic aneurysm repair. It is FDA PMA cleared with evidence from two studies indicating its use in complex aneurysm cases.
FDA Clearance Information
Pathway ?
PMA
Number ?
P020018 ↗
Decision Date ?
December 14, 2023
Product Code ?
MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Device Class ?
Class 3
Evidence ?
35 studies
The device received FDA clearance through the PMA pathway on December 14, 2023. Manufactured by Cook, it is classified as a Class 3 medical device.
What It Is
The Zenith R Fenestrated AAA Endovascular Graft is an endovascular system used to treat abdominal aortic aneurysms. It features a fenestrated design to accommodate complex vascular anatomies and is intended for use in patients with specific aneurysm characteristics.
FDA-Cleared Indications
- Addition of a different form of the inner PTFE liner material used in the Zenith Introduction Systems.
Clinical Applications
- Endovascular repair of abdominal aortic aneurysms using a covered stent-graft system.
- Treatment of selected complex abdominal aortic aneurysms with anatomy requiring fenestrations to preserve flow to branch vessels, when permitted by the device labeling.
- Delivery of the endovascular graft through the Zenith Introduction System during image-guided aortic repair.
Evidence Summary
The available literature includes two clinical studies registered on ClinicalTrials.gov. These studies focus on the use of fenestrated stent grafts in complex aneurysm repair, though specific sample sizes and outcomes are not detailed.
Reported Outcomes
Published studies report that the Zenith R Fenestrated AAA Endovascular Graft is effective in managing complex abdominal aortic aneurysms. However, detailed efficacy data such as success rates or long-term outcomes are not provided in the available evidence.
Safety Profile
Reported complications include typical risks associated with endovascular procedures, though specific adverse events are not detailed in the provided studies. Further research is needed to comprehensively assess safety profiles.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data in the available studies. Further research is necessary to establish long-term efficacy and safety, as well as to explore outcomes in diverse patient populations.
Practical Considerations
- Use requires detailed preprocedural CT angiography to assess the aorta, aneurysm morphology, access vessels, landing zones, and the location of renal or other branch vessels.
- Fenestrated configurations must be selected and aligned to the relevant branch vessels; device availability, customization, and sizing depend on the approved product configuration.
- The system is delivered through an arterial access site, commonly the common femoral artery, under fluoroscopic imaging and usually with general anesthesia or regional anesthesia with sedation.
- MRI safety depends on the exact implanted graft components and current manufacturer labeling; the implant card and product instructions should be reviewed before MRI.
- Contraindications and limitations include unsuitable aortic or iliac anatomy, inadequate landing or fixation zones, incompatible access vessels, active infection, or inability to receive the required contrast imaging and antithrombotic management.
Linked Studies (20)
PubMed • 2025
Outcomes of patients with acute complicated type B aortic dissections repaired with the Zenith dissection endovascular system compared to aortic stent graft.
Vascular
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Gingival zenith level, position, and symmetry: A systematic review and meta-analysis.
The Journal of prosthetic dentistry
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Expert-Based Narrative Review on Contemporary Use of an Off-The-Shelf Multibranched Endograft for Endovascular Treatment of Thoracoabdominal Aortic Aneurysms: Device Design, Anatomical Suitability, Technical Tips, Perioperative Care, Clinical Applications, and Real-World Experience.
Annals of vascular surgery
View Source →PubMed • 2024
Exploring atmospheric optical turbulence: observations across zenith angles.
Applied optics
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Cook Zenith Alpha Endograft: A Protocol to Minimise Limb Graft Occlusion.
European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Gingival Zenith Correction by Laser Gingivectomy.
Cureus
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
Emergent endovascular treatment options for thoracoabdominal aortic aneurysm.
Seminars in vascular surgery
View Source →PubMed • 2023
Commentary: Data zenith.
The Journal of thoracic and cardiovascular surgery
View Source →PubMed • 2022
Placement of a Zenith® Dissection Endovascular System in the Descending Thoracic Aorta Can Hamper Further Surgical Aortic Operations.
EJVES vascular forum
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2022
Midterm outcomes of aneurysm repair with the Cook Zenith Alpha abdominal endovascular graft.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2021
Comparison of anatomic feasibility of three different multibranched off-the-shelf stent-grafts designed for thoracoabdominal aortic aneurysms.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2021
New Technical Approach to Overcome Anatomical Challenges During Branched Endovascular Aortic Repair with off-the-Shelf Multibranched Stent-Grafts: Are We Sequentially and Progressively Scraping the Sky? : Commentary on "Sequential catheterization and progressive deployment of the Zenith tBranchTM device for branched endovascular aortic aneurysm repair".
Cardiovascular and interventional radiology
View Source →PubMed • 2021
Kinematic Zenith Tropospheric Delay Estimation with GNSS PPP in Mountainous Areas.
Sensors (Basel, Switzerland)
View Source →PubMed • 2020
Five-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study of endovascular treatment of complicated type B aortic dissection using a composite device design.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2020
Physician-Modified Endograft With Double Inner Branches for Urgent Repair of Supraceliac Para-Anastomotic Pseudoaneurysm.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2019
Device profile of the Zenith Dissection Endovascular System for aortic dissection.
Expert review of medical devices
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2016
Thoracic endovascular aortic repair for complicated chronic type B aortic dissection in a patient on hemodialysis with recurrent ischemic colitis.
Surgical case reports
Case Series View Source →PubMed • 2015
Surgeon custom-made iliac branch device to salvage hypogastric artery during endovascular aneurysm repair.
Journal of Korean medical science
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2014
Experience of the Zenith Dissection Endovascular System in the emergency setting of malperfusion in acute type B dissections.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for Zenith R Fenestrated AAA Endovascular Graft?
The device is indicated for the endovascular repair of complex abdominal aortic aneurysms, particularly in anatomies unsuitable for standard grafts.
What outcomes have been reported in clinical studies?
The studies indicate effectiveness in complex aneurysm repair, but specific outcome data are not detailed.
What complications have been reported?
Reported complications include general risks of endovascular procedures, though specific adverse events are not detailed in the studies.
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.