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AneurX Stent Graft With Xpedirnt Delivery System

FDA PMA

Class III (US FDA PMA)

PMA P990020

by Medtronic Vascular

Identity

Trade Name
ANEURX STENT GRAFT SYSTEM FDA PMA
Generic Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT FDA PMA

Identifiers

PMA Number
P990020 FDA PMA
FDA Product Code
MIH FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APWD FDA PMA

The AneurX Stent Graft System is an endovascular graft designed for the treatment of infra renal abdominal aortic or aorto-iliac aneurysms. It consists of a stent graft and an Xpedirnt delivery system, providing a minimally invasive option for patients with suitable anatomy.

This device is intended for patients with adequate iliac/femoral access, specific neck measurements, and aneurysm morphology suitable for endovascular repair. The AneurX Stent Graft System is supplied as a single-use device and requires proper storage conditions. It has received FDA PMA authorization for the specified indications.

Frequently asked questions

What is the AneurX Stent Graft System used for?

The AneurX Stent Graft System is used for the endovascular treatment of infra renal abdominal aortic or aorto-iliac aneurysms in patients who meet specific anatomical criteria, including adequate access vessels, appropriate neck length, and suitable aneurysm morphology.

What are the anatomical requirements for using the AneurX Stent Graft System?

Patients must have adequate iliac/femoral access, an infrarenal non-aneurysmal neck length of at least 1 cm at both ends of the aneurysm, and a vessel diameter 10-20% smaller than the labeled device diameter. Additionally, the aneurysm must have a diameter greater than 5cm, or be between 4-5cm with documented growth, or be twice the diameter of the normal infrarenal aorta.

Is the AneurX Stent Graft System reusable?

No, the AneurX Stent Graft System is designed as a single-use device and should not be reused or resterilized. Each system is supplied in sterile packaging and should be handled according to the manufacturer's instructions to maintain device integrity and patient safety.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA PMA P990020 24 fields · synced Oct 6, 2026