Identity
- Trade Name
- MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM FDA PMA
- Generic Name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT FDA PMA
Identifiers
- PMA Number
- P100021 FDA PMA
- FDA Product Code
- MIH FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Endurant Stent Graft System is an endovascular graft designed for the treatment of infrarenal abdominal aortic or aorto-iliac aneurysms. It is classified as a System, Endovascular Graft, for Aortic Aneurysm Treatment, intended to reinforce and exclude aneurysmal segments of the aorta through minimally invasive endovascular techniques.
This device is supplied in multiple sizes and configurations, tailored to specific anatomical parameters including aortic neck diameters (19–32 mm), iliac diameters (8–25 mm), and proximal neck length (≥10 mm). It is intended for use in patients with adequate iliac or femoral access, proximal neck angulation ≤60 degrees, and distal fixation length ≥15 mm. The system is approved for single-use and requires sterile handling, with regulatory authorisation under FDA PMA (P100021).
Frequently asked questions
What anatomical and access requirements must be met for a patient to be considered suitable for the Endurant Stent Graft System?
The Endurant Stent Graft System is designed for patients with infrarenal abdominal aortic or aorto-iliac aneurysms who have adequate iliac or femoral access compatible with vascular techniques. Key anatomical criteria include a proximal neck length of at least 10 mm, neck angulation no greater than 60 degrees, and a distal fixation length of at least 15 mm. Additionally, the aortic neck diameter must range between 19–32 mm, and iliac diameters must fall within 8–25 mm. These specifications ensure proper placement and fixation of the graft.
How is the Endurant Stent Graft System supplied, and what considerations should be made regarding sterility and usage?
The Endurant Stent Graft System is supplied in multiple sizes and configurations to match specific anatomical parameters. It is intended for **single-use only** and requires sterile handling, as per FDA guidelines. This ensures patient safety and prevents contamination during the minimally invasive endovascular procedure.
What regulatory pathway was followed for the approval of the Endurant Stent Graft System, and how does this affect its use?
The Endurant Stent Graft System received approval through the FDA’s **Premarket Approval (PMA)** process, specifically under PMA number **P100021**. This pathway is typically reserved for higher-risk devices, ensuring rigorous evaluation of safety and effectiveness before clinical use. Clinicians and buyers should confirm compliance with the approved indications and anatomical requirements outlined in the PMA authorization.
Are there different models or sizes available for the Endurant Stent Graft System, and how do they relate to patient anatomy?
Yes, the Endurant Stent Graft System is available in multiple sizes tailored to specific anatomical measurements. It accommodates aortic neck diameters ranging from **19–32 mm** and iliac diameters from **8–25 mm**, ensuring compatibility with diverse patient anatomies. The system’s configurations also account for neck length, angulation, and fixation length requirements, allowing for precise customization during treatment planning.
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
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P100021 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA PMA P100021 24 fields · synced Oct 6, 2026