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zenith flex system
Inneuro
Summary: The Zenith Flex System is an endovascular stent graft used primarily for the repair of abdominal aortic aneurysms. Key evidence includes its applicability in diverse anatomical scenarios and its performance in real-world settings.
FDA Clearance Information
Pathway
510K
Number
K172167 ↗
Decision Date
April 19, 2018
Product Code
NRY
Device Class
Class 2
Evidence
35 studies
The Zenith Flex System was cleared by the FDA via the 510(k) pathway on April 19, 2018. It is manufactured by Inneuro and classified as a Class 2 medical device.
What It Is
The Zenith Flex System is an endovascular stent graft designed for the treatment of abdominal aortic aneurysms. It functions by providing a scaffold to support the aorta and prevent aneurysm rupture.
Clinical Applications
Commonly used in endovascular aneurysm repair (EVAR) procedures, the Zenith Flex System is indicated for patients with abdominal aortic aneurysms, particularly those with challenging aortoiliac anatomies.
Evidence Summary
The available literature includes randomized controlled trials and retrospective studies, with a total of 7 studies ranging from 2014 to 2023. These studies evaluate the device's applicability, safety, and performance.
Reported Outcomes
Published studies report that the Zenith Flex System is effective in accommodating a wide range of aortoiliac anatomies, improving patient eligibility for EVAR. The LEOPARD trial highlights its performance in real-world populations, demonstrating favorable outcomes over a five-year period.
Safety Profile
Reported complications include issues related to stent graft pullout forces, particularly with increased angulation. However, the studies emphasize the device's overall safety profile in diverse anatomical conditions.
Evidence Limitations
Current evidence is limited by the lack of long-term follow-up data and the need for more comprehensive studies on the device's performance in varied patient populations. Further research is needed to explore its long-term efficacy and safety.
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 Flex System?
The Zenith Flex System is indicated for the endovascular repair of abdominal aortic aneurysms, particularly in patients with complex aortoiliac anatomies.
What outcomes have been reported in clinical studies?
Studies report effective aneurysm repair and improved patient eligibility for EVAR, with favorable outcomes in real-world settings.
What complications have been reported?
Safety data indicate complications related to stent graft pullout forces, especially with increased angulation, but overall safety is maintained.
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.