đź“‹ FDA Reference
074 Zenith Flex System
Inneuro
Product: Axs Vecta 74 — all models and sizes
Summary: The 074 Zenith Flex System is an aortic stent graft used primarily in endovascular procedures to treat aortic aneurysms. It is typically used by vascular surgeons in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K181354 ↗
Decision Date ?
October 25, 2018
Product Code ?
NRY Catheter, Thrombus Retriever
Device Class ?
Class 2
Evidence ?
35 studies
The 074 Zenith Flex System was cleared through the FDA 510k pathway on October 25, 2018. Manufactured by Inneuro, it is classified as a Class 2 medical device under product code NRY.
What It Is
The 074 Zenith Flex System is an endovascular stent graft designed to reinforce weakened sections of the aorta, particularly in cases of aneurysms. It consists of a fabric tube supported by a metal framework that is delivered via catheter to the affected area. Once in place, it provides structural support to the aortic wall, reducing the risk of rupture.
FDA-Cleared Indications
- The supplied FDA indication summary states that the device is intended for treatment of aortic aneurysms.
- The device is intended to reinforce the aortic wall and reduce the risk of aneurysm rupture.
- The listed product code and description should be confirmed because product code NRY is associated with a thrombus-retrieval catheter, not an aortic endovascular stent graft.
Clinical Applications
- Endovascular repair of an appropriately selected aortic aneurysm using a stent-graft approach.
- Placement of a fabric-covered metal endovascular graft to exclude an aneurysm from blood flow.
- Treatment planning based on aneurysm location, aortic diameter, vessel access, and available proximal and distal landing zones.
Practical Considerations
- Confirm the manufacturer, device name, FDA 510(k) record, product code, and official instructions for use; the supplied record contains a device-description and product-code mismatch.
- Device selection requires detailed cross-sectional imaging to assess aortic diameter, aneurysm anatomy, landing zones, access vessels, and vessel tortuosity.
- Deployment is performed through catheter access, commonly through the femoral or iliac arteries, under fluoroscopic imaging and usually with moderate sedation or general anesthesia depending on the procedure.
- MRI safety, conditional labeling, compatibility, and follow-up imaging requirements must be taken from the current manufacturer instructions for use; they should not be inferred from the device name alone.
- Contraindications and precautions may include unsuitable anatomy, active infection, inability to tolerate contrast or the procedure, and inadequate access or landing zones.
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 is 074 Zenith Flex System used for?
It is used to treat aortic aneurysms by providing structural support to the aorta, reducing the risk of rupture.
What specialties typically use this device?
Vascular surgeons typically use this device in endovascular procedures.
What are the FDA-cleared indications?
It is indicated for the treatment of aortic aneurysms, particularly in patients who are not candidates for open surgery.
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.