📊 Evidence-Based Reference

zenith tx2 thoracic taa endovascular graft with the h lb one-shot introduction system

William Cook Europe Aps

Summary: The Zenith TX2 Thoracic TAA Endovascular Graft is an endovascular device used for treating thoracic aortic aneurysms and ulcers. Key evidence highlights its effectiveness in endovascular repair with a focus on safety and outcomes.

FDA Clearance Information

Pathway PMA
Decision Date May 21, 2008
Product Code MIH
Device Class Class 3
Evidence 35 studies

The Zenith TX2 Thoracic TAA Endovascular Graft was cleared by the FDA via the PMA pathway on May 21, 2008. Manufactured by William Cook Europe Aps, it is classified as a Class 3 medical device.

What It Is

The Zenith TX2 Thoracic TAA Endovascular Graft is designed for endovascular treatment of descending thoracic aortic aneurysms and ulcers. It utilizes the H&LB One-Shot Introduction System for precise deployment, offering a minimally invasive alternative to open surgical repair.

Clinical Applications

This device is commonly used in patients with suitable vascular morphology for endovascular repair, particularly those with adequate iliac/femoral access and non-aneurysmal aortic segments proximal and distal to the aneurysm or ulcer.

Evidence Summary

The available literature includes 8 studies, comprising various study types such as RCTs, prospective, and retrospective analyses. The studies span from 2011 to 2019, providing a comprehensive overview of the device's clinical performance.

Reported Outcomes

Published studies report that the Zenith TX2 Thoracic TAA Endovascular Graft is effective in achieving endovascular repair of thoracic aortic aneurysms, with positive outcomes in terms of mortality and morbidity compared to open repair. The device has shown success in closing the primary intimal entry tear and promoting thrombosis of the false lumen.

Safety Profile

Reported complications include typical risks associated with endovascular procedures, such as endoleaks, device migration, and access site complications. However, the studies emphasize a favorable safety profile with no significant increase in adverse events compared to other endovascular systems.

Evidence Limitations

The evidence is limited by the variability in study designs and the lack of long-term follow-up data. Further research is needed to assess the long-term durability and effectiveness of the device in diverse patient populations.

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 TX2 Thoracic TAA Endovascular Graft?

The device is indicated for endovascular treatment of descending thoracic aortic aneurysms and ulcers in patients with suitable vascular morphology, including adequate iliac/femoral access and non-aneurysmal aortic segments for fixation.

What outcomes have been reported in clinical studies?

Clinical studies have reported positive outcomes in terms of mortality and morbidity, with effective closure of the primary intimal entry tear and thrombosis of the false lumen.

What complications have been reported?

Safety data from evidence indicate complications such as endoleaks, device migration, and access site complications, though the overall safety profile is favorable.

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.

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