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Cadwell Zenith System
Cadwell Industries
Summary: The Cadwell Zenith System is a Class 2 medical device used in the deployment of aortic stent-grafts. It is primarily utilized by vascular surgeons and interventional radiologists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K181466 ↗
Decision Date ?
September 1, 2018
Product Code ?
GWQ
Device Class ?
Class 2
Evidence ?
35 studies
The Cadwell Zenith System was cleared through the FDA 510(k) pathway on September 1, 2018. Manufactured by Cadwell Industries, it is classified as a Class 2 device under product code GWQ.
What It Is
The Cadwell Zenith System is a medical device designed to assist in the placement of aortic stent-grafts. It provides precise control and deployment of stent-grafts within the aorta, which is crucial in treating conditions such as aortic aneurysms. The system is engineered to enhance the accuracy and safety of endovascular procedures.
FDA-Cleared Indications
- Deployment of aortic stent-grafts.
- Use during endovascular treatment of aortic conditions requiring placement of an aortic stent-graft.
Clinical Applications
- Delivering and deploying an aortic stent-graft through catheter-based access.
- Supporting endovascular repair of an aortic aneurysm when the selected stent-graft and anatomy meet their labeling requirements.
- Positioning an aortic stent-graft within the aorta under fluoroscopic imaging.
- Use in a hospital operating room, hybrid operating room, or catheterization laboratory by trained clinicians.
Practical Considerations
- The delivery system must be matched to the specific stent-graft, graft size, access vessel, and patient anatomy.
- Deployment requires fluoroscopic imaging and careful control of graft position within the aorta.
- Femoral or iliac arterial access is commonly used, although the access approach depends on the procedure and the device configuration.
- Clinicians should review the current instructions for use for compatibility, vessel diameter, tortuosity, access-site requirements, contraindications, and handling.
- MRI safety depends on the implanted stent-graft and its labeling; the delivery system is removed after deployment and should not be considered an implanted device.
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 the Cadwell Zenith System used for?
It is used for the deployment of aortic stent-grafts in endovascular procedures.
What specialties typically use this device?
Vascular surgeons and interventional radiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in deploying aortic stent-grafts, particularly for patients with aortic aneurysms.
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.