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oria zenith
Ortho Tec
Summary: The Oria Zenith is an aortic stent-graft designed for endovascular repair of thoracoabdominal aortic aneurysms. Key evidence highlights its efficacy in complex aortic repairs with some reported complications.
FDA Clearance Information
Pathway 510K
Number K030500 ↗
Decision Date March 20, 2003
Product Code KWQ
Device Class Class 2
Evidence 35 studies
The Oria Zenith was cleared by the FDA through the 510(k) pathway on March 20, 2003. It is manufactured by Ortho Tec and classified as a Class 2 medical device.
What It Is
The Oria Zenith is an aortic stent-graft used in endovascular procedures to treat thoracoabdominal aortic aneurysms. It is designed to provide a minimally invasive option for repairing complex aortic aneurysms.
Clinical Applications
Commonly used in the treatment of thoracoabdominal aortic aneurysms, the Oria Zenith is applied in scenarios where traditional surgical approaches are not feasible. It offers a less invasive alternative for patients with complex aortic conditions.
Evidence Summary
The available literature includes a mix of randomized controlled trials, prospective and retrospective studies, and case series, with a total of 8 studies published between 2023 and 2025.
Reported Outcomes
Published studies report that the Oria Zenith is effective in the endovascular repair of thoracoabdominal aortic aneurysms, with successful outcomes in complex cases. The device has shown promise in reducing procedural risks associated with open surgery.
Safety Profile
Reported complications include device-related adverse events such as distal stent-graft induced new entry (dSINE) and issues related to the structural integrity of the aortic wall. These complications highlight the need for careful patient selection and monitoring.
Evidence Limitations
The evidence is limited by the small number of studies and the variability in study design. Further research is needed to establish long-term outcomes and to refine patient selection criteria.
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 Oria Zenith?
The Oria Zenith is indicated for the endovascular repair of thoracoabdominal aortic aneurysms, particularly in patients where open surgery is not an option.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful repair of complex aortic aneurysms with the Oria Zenith, demonstrating its efficacy in reducing procedural risks.
What complications have been reported?
Safety data from evidence indicate complications such as distal stent-graft induced new entry (dSINE) and issues with aortic wall integrity.
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.