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046 zenith flex
Inneuro
Summary: The 046 Zenith Flex is an aortic stent graft used in endovascular procedures to treat aortic aneurysms. It is typically used by vascular surgeons and interventional radiologists.
FDA Clearance Information
Pathway 510K
Number K190338 ↗
Decision Date August 2, 2019
Product Code NRY
Device Class Class 2
Evidence 35 studies
The 046 Zenith Flex, manufactured by Inneuro, was cleared by the FDA via the 510(k) pathway on August 2, 2019. It is a Class 2 medical device under product code NRY.
What It Is
The 046 Zenith Flex is an endovascular stent graft designed to treat aortic aneurysms. It is deployed via a catheter-based system, allowing for minimally invasive placement within the aorta. The device supports the weakened section of the aorta, preventing rupture by redirecting blood flow through the stent graft.
Clinical Applications
This device is primarily used in the treatment of abdominal and thoracic aortic aneurysms. It is commonly employed in vascular surgery and interventional radiology settings. Patients who are high-risk for open surgical repair due to comorbidities often benefit from this minimally invasive approach.
Indications for Use
The 046 Zenith Flex is indicated for patients with aortic aneurysms, which are bulging or weakened areas in the aorta that risk rupture. It is suitable for those who require endovascular repair due to the location and size of the aneurysm.
Practical Considerations
The device comes in various sizes to accommodate different patient anatomies and is compatible with standard endovascular delivery systems. Proper sizing and placement technique are crucial to ensure optimal outcomes and reduce the risk of complications.
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 046 Zenith Flex used for?
The 046 Zenith Flex is used to treat aortic aneurysms by providing structural support to the aorta and preventing rupture.
What specialties typically use this device?
Vascular surgeons and interventional radiologists typically use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for the endovascular treatment of aortic aneurysms, particularly in patients who are at high risk for open surgical repair.
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.