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Zenith Alpha Thoracic Endovascular Graft

by Cook Medical Incorporated

PMA P140016

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P140016↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP140016 Date15 Sep 2015ApprovedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0043-2026 FDA Class I initiated 18 Sep 2025

    Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.

    • Terminated Z-2099-2017 FDA Class I initiated 22 Mar 2017

    There have been five reports of graft thrombosis/occlusion during global commercial use, each following treatment for BTAI. One case resulted in patient death, and three cases resulted in reintervention.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
PMA Number
FDA Product Code
MIH
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Zenith Alpha Thoracic Endovascular Graft is a System, Endovascular Graft, Aortic Aneurysm Treatment designed for endovascular repair of isolated lesions in the descending thoracic aorta. It is intended for patients with non-dissection aneurysms or aneurysmal dilations where vascular anatomy permits endovascular access and fixation, including suitable iliac/femoral access and non-aneurysmal aortic segments proximal and distal to the lesion.

This device is supplied in multiple sizes (ranging from 15 mm to 42 mm outer wall diameter) and is implanted via percutaneous or surgical access under fluoroscopic guidance. It is classified as a Class III medical device under FDA regulations and requires FDA_PMA approval. Sterility and single-use specifications are not explicitly stated in the provided data, but it is intended for one-time surgical use in a controlled clinical setting.

Other devices from Cook Medical Incorporated

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What specific types of aortic conditions is the Zenith Alpha Thoracic Endovascular Graft designed to treat?

    The Zenith Alpha Thoracic Endovascular Graft is specifically designed for endovascular repair of isolated lesions in the descending thoracic aorta, such as non-dissection aneurysms or aneurysmal dilations. It is not intended for treating aortic dissections. The device requires suitable vascular anatomy, including accessible iliac/femoral arteries and non-aneurysmal aortic segments (at least 20 mm long) both proximal and distal to the lesion.

  • How is the Zenith Alpha Thoracic Endovascular Graft implanted, and what guidance is used during the procedure?

    The device is implanted via either percutaneous or surgical access under fluoroscopic guidance. This means real-time X-ray imaging is used to ensure precise placement of the graft within the descending thoracic aorta during the procedure.

  • What size options are available for the Zenith Alpha Thoracic Endovascular Graft, and how does this relate to patient anatomy?

    The device comes in multiple sizes, with outer wall diameters ranging from 15 mm to 42 mm. These sizes correspond to the diameter of the patient’s aorta at the lesion site, ensuring a proper fit for effective sealing and fixation. The proximal and distal fixation sites must also be non-aneurysmal and within this diameter range.

  • Is the Zenith Alpha Thoracic Endovascular Graft intended for single-use or reusable applications?

    While the provided data does not explicitly state sterility or reuse specifications, the device is intended for one-time surgical use in a controlled clinical setting, which implies it is designed as a single-use product. This aligns with standard practices for endovascular grafts to ensure patient safety and sterility.

  • What regulatory pathway was followed for the approval of the Zenith Alpha Thoracic Endovascular Graft?

    The Zenith Alpha Thoracic Endovascular Graft was approved through the FDA’s Premarket Approval (PMA) process, which is required for Class III medical devices. This pathway ensures rigorous evaluation of safety and effectiveness before market authorization. The device holds PMA number P140016 and was approved on September 15, 2015.