📋 FDA Reference

Zenith R Alpha Thoracic Endovascular Graft

Cook Medical

Product: Zenith Alpha — all models and sizes

Summary: The Zenith R Alpha Thoracic Endovascular Graft is a device used in endovascular procedures to treat thoracic aortic aneurysms. It is primarily used by vascular surgeons and interventional radiologists.

FDA Clearance Information

Pathway ? PMA

Number ? P140016 ↗

Decision Date ? September 25, 2024

Product Code ? MIH System, Endovascular Graft, Aortic Aneurysm Treatment

Device Class ? Class 3

Evidence ? 35 studies

The Zenith R Alpha Thoracic Endovascular Graft, manufactured by Cook Medical, received FDA clearance under PMA P140016 on September 25, 2024. It is a Class 3 medical device.

What It Is

The Zenith R Alpha Thoracic Endovascular Graft is a stent-graft system designed for endovascular repair of thoracic aortic aneurysms. It consists of a fabric-covered stent that is delivered via a catheter-based system to reinforce the weakened section of the aorta. This minimally invasive device helps prevent aneurysm rupture by providing structural support to the aortic wall.

FDA-Cleared Indications

Approved changes to the introduction systems for the proximal and distal components of the Zenith Alpha Thoracic Endovascular Graft System.
Approved changes to the distal extension of the Zenith Alpha Thoracic Endovascular Graft System.

Clinical Applications

Endovascular repair of appropriately selected thoracic aortic aneurysms using the Zenith Alpha Thoracic Endovascular Graft System.
Use of the revised delivery or introduction systems for placement of proximal and distal graft components.
Use of the approved distal extension component when additional graft coverage is required within the labeled thoracic aortic anatomy.
Treatment in a hospital or specialized vascular center by clinicians trained in thoracic endovascular aortic repair.

Practical Considerations

The graft and delivery system must be selected to match the patient's aortic diameter, landing zones, vessel access anatomy, and required treatment length.
Preprocedure CT angiography is typically used to assess the thoracic aorta, branch vessels, landing zones, and femoral or iliac access vessels.
Deployment requires fluoroscopic imaging and careful control of the delivery system; accurate positioning is important to maintain a seal and avoid covering important branch vessels.
Patients require follow-up imaging because endoleak, graft migration, component separation, aneurysm enlargement, or other device-related complications can occur.
MRI conditions depend on the complete implanted system and current manufacturer labeling. The specific graft configuration should be checked in the current instructions for use before MRI.

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 Zenith R Alpha Thoracic Endovascular Graft used for?

It is used for the endovascular repair of thoracic aortic aneurysms to prevent rupture.

What specialties typically use this device?

Vascular surgeons and interventional radiologists typically use this device.

What are the FDA-cleared indications?

It is indicated for use in endovascular procedures involving changes to introduction systems for proximal and distal components and the distal extension of the graft system.

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.

💲 Procedure Costs

📄 Articles

Zenith R Alpha Thoracic Endovascular Graft

FDA Clearance Information

What It Is

FDA-Cleared Indications

Clinical Applications

Practical Considerations

Linked Studies (20)

Outcomes of patients with acute complicated type B aortic dissections repaired with the Zenith dissection endovascular system compared to aortic stent graft.

Gingival zenith level, position, and symmetry: A systematic review and meta-analysis.

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.

Exploring atmospheric optical turbulence: observations across zenith angles.

Cook Zenith Alpha Endograft: A Protocol to Minimise Limb Graft Occlusion.

Gingival Zenith Correction by Laser Gingivectomy.

A Retrospective Evaluation of Intra-Prosthetic Thrombus Formation After Endovascular Aortic Repair in Cook Zenith Alpha and Medtronic Endurant II Patients.

Emergent endovascular treatment options for thoracoabdominal aortic aneurysm.

Commentary: Data zenith.

Placement of a Zenith® Dissection Endovascular System in the Descending Thoracic Aorta Can Hamper Further Surgical Aortic Operations.

Midterm outcomes of aneurysm repair with the Cook Zenith Alpha abdominal endovascular graft.

Comparison of anatomic feasibility of three different multibranched off-the-shelf stent-grafts designed for thoracoabdominal aortic aneurysms.

Kinematic Zenith Tropospheric Delay Estimation with GNSS PPP in Mountainous Areas.

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.

Physician-Modified Endograft With Double Inner Branches for Urgent Repair of Supraceliac Para-Anastomotic Pseudoaneurysm.

Device profile of the Zenith Dissection Endovascular System for aortic dissection.

Thoracic endovascular aortic repair for complicated chronic type B aortic dissection in a patient on hemodialysis with recurrent ischemic colitis.

Surgeon custom-made iliac branch device to salvage hypogastric artery during endovascular aneurysm repair.

Experience of the Zenith Dissection Endovascular System in the emergency setting of malperfusion in acute type B dissections.

Frequently Asked Questions

What is Zenith R Alpha Thoracic Endovascular Graft used for?

What specialties typically use this device?

What are the FDA-cleared indications?

Suggest edits

Thank you

FDA Clearance Information

What It Is

FDA-Cleared Indications

Clinical Applications

Practical Considerations

Linked Studies (20)

Outcomes of patients with acute complicated type B aortic dissections repaired with the Zenith dissection endovascular system compared to aortic stent graft.

Gingival zenith level, position, and symmetry: A systematic review and meta-analysis.

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.

Exploring atmospheric optical turbulence: observations across zenith angles.

Cook Zenith Alpha Endograft: A Protocol to Minimise Limb Graft Occlusion.

Gingival Zenith Correction by Laser Gingivectomy.

A Retrospective Evaluation of Intra-Prosthetic Thrombus Formation After Endovascular Aortic Repair in Cook Zenith Alpha and Medtronic Endurant II Patients.

Emergent endovascular treatment options for thoracoabdominal aortic aneurysm.

Commentary: Data zenith.

Placement of a Zenith® Dissection Endovascular System in the Descending Thoracic Aorta Can Hamper Further Surgical Aortic Operations.

Midterm outcomes of aneurysm repair with the Cook Zenith Alpha abdominal endovascular graft.

Comparison of anatomic feasibility of three different multibranched off-the-shelf stent-grafts designed for thoracoabdominal aortic aneurysms.

Kinematic Zenith Tropospheric Delay Estimation with GNSS PPP in Mountainous Areas.

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.

Physician-Modified Endograft With Double Inner Branches for Urgent Repair of Supraceliac Para-Anastomotic Pseudoaneurysm.

Device profile of the Zenith Dissection Endovascular System for aortic dissection.

Thoracic endovascular aortic repair for complicated chronic type B aortic dissection in a patient on hemodialysis with recurrent ischemic colitis.

Surgeon custom-made iliac branch device to salvage hypogastric artery during endovascular aneurysm repair.

Experience of the Zenith Dissection Endovascular System in the emergency setting of malperfusion in acute type B dissections.

Frequently Asked Questions

What is Zenith R Alpha Thoracic Endovascular Graft used for?

What specialties typically use this device?

What are the FDA-cleared indications?

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