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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
510K
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.
Clinical Applications
This device is commonly used in endovascular procedures to treat aortic aneurysms and other aortic pathologies. Vascular surgeons and interventional radiologists utilize the system in operating rooms and catheterization labs. It is particularly beneficial for patients requiring minimally invasive treatment of aortic diseases.
Indications for Use
The FDA-cleared indications for the Cadwell Zenith System involve its use in the deployment of aortic stent-grafts. It is intended for patients with aortic aneurysms or other conditions requiring reinforcement of the aortic wall.
Practical Considerations
The Cadwell Zenith System is compatible with a range of stent-graft sizes, allowing for flexibility in treating different patient anatomies. Clinicians should be familiar with the device's deployment mechanism and ensure proper sizing and positioning during procedures.
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.