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zenith dissection endovascular system
William Cook Europe Aps
Summary: The Zenith Dissection Endovascular System is an endovascular device used for the treatment of acute, complicated type B aortic dissection. Key evidence suggests its effectiveness in reducing complications associated with traditional stent grafts.
FDA Clearance Information
Pathway
PMA
Number
P180001 ↗
Decision Date
July 9, 2024
Product Code
MIH
Device Class
Class 3
Evidence
35 studies
The Zenith Dissection Endovascular System was cleared through the FDA PMA pathway on July 9, 2024. It is manufactured by William Cook Europe Aps and classified as a Class 3 medical device.
What It Is
The Zenith Dissection Endovascular System is designed for endovascular repair of acute, complicated type B aortic dissections. It combines a proximal covered stent graft with a distal bare metal stent to provide structural support and promote healing.
Clinical Applications
This device is commonly used in the management of acute, complicated type B aortic dissections, particularly in cases involving aortic rupture or malperfusion. It is intended for use in patients who require endovascular intervention to stabilize the aorta.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series, published between 2020 and 2025. These studies evaluate the safety and efficacy of the device in clinical settings.
Reported Outcomes
Published studies report that the Zenith Dissection Endovascular System is effective in reducing complications associated with acute, complicated type B aortic dissections. The device has shown favorable outcomes in terms of aortic stability and reduced need for additional surgical interventions.
Safety Profile
Reported complications include potential aortic events that may necessitate further surgical intervention. Some studies highlight the importance of achieving adequate proximal seal length to minimize complications.
Evidence Limitations
The current evidence is limited by the variability in study designs and patient populations. Further research is needed to establish long-term outcomes and to compare the device's performance against other endovascular systems.
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 Zenith Dissection Endovascular System?
The device is indicated for the endovascular repair of acute, complicated type B aortic dissections, particularly in cases of aortic rupture or malperfusion.
What outcomes have been reported in clinical studies?
Studies report effective reduction in complications and improved aortic stability, with favorable outcomes in patients treated for acute, complicated type B aortic dissections.
What complications have been reported?
Reported complications include aortic events that may require surgical intervention, with some studies emphasizing the importance of proximal seal length to minimize risks.
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.