Zenith (flex) Aaa Endovascular Graft, Zenith Renu Aaa Ancillary Graft, Zenith F…
FDA PMAClass III (US FDA PMA)
by Cook, Inc.
Identity
- Trade Name
- ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM FDA PMA
- Generic Name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT FDA PMA
Identifiers
- PMA Number
- P020018 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 Zenith Flex AAA Endovascular Graft, Zenith Renu AAA Ancillary Graft, and Zenith Fenestrated AAA Endovascular Graft are endovascular devices designed for the treatment of abdominal aortic or aorto-iliac aneurysms. These grafts are intended for patients with aneurysm morphology suitable for endovascular repair, providing a non-surgical alternative to open aortic surgery by reinforcing weakened arterial walls and restoring blood flow through a stent-graft system.
The system is supplied as a sterile, single-use device and is approved for use in the United States under an FDA Premarket Approval (PMA P020018). It is intended for deployment via endovascular techniques, requiring specialized interventional radiology or vascular surgery settings. The grafts are available in various sizes and configurations, including fenestrated and ancillary variants, to accommodate different anatomical requirements. Storage and handling must comply with sterile medical device protocols.
Frequently asked questions
What types of aneurysms is the Zenith system designed to treat, and how does it differ from open surgery?
The Zenith system is designed for endovascular treatment of abdominal aortic or aorto-iliac aneurysms in patients whose anatomy is suitable for this approach. Unlike open surgery, which involves a major incision and direct repair of the aorta, the Zenith system provides a non-surgical alternative by reinforcing weakened arterial walls with a stent-graft deployed via catheterization. This minimizes trauma, reduces recovery time, and avoids the need for general anesthesia.
Is the Zenith system single-use, and how should it be stored to maintain sterility?
Yes, the Zenith system is supplied as a sterile, single-use device. To maintain sterility, it must be stored according to standard sterile medical device protocols, typically in its original packaging until ready for use. Avoid exposure to moisture, extreme temperatures, or contamination, as these can compromise integrity.
What anatomical variations does the Zenith system accommodate, and how are the different graft types (e.g., fenestrated, ancillary) used?
The Zenith system includes multiple graft types—such as the Flex AAA, Renu Ancillary, and Fenestrated variants—to address diverse anatomical requirements. Fenestrated grafts feature pre-made openings to preserve blood flow to branching arteries (e.g., renal arteries), while ancillary grafts extend coverage for complex anatomies. The Flex variant offers enhanced flexibility for tortuous vessels. Each variant is tailored to specific aneurysm morphologies, ensuring a customized repair.
Where and by whom should the Zenith system be deployed, and what specialized setting is required?
The Zenith system is intended for deployment in specialized interventional radiology or vascular surgery settings by trained professionals, such as interventional radiologists or vascular surgeons. These procedures require advanced imaging guidance (e.g., fluoroscopy) and a team experienced in endovascular techniques to ensure precise placement and optimal outcomes.
How do I verify the regulatory approval status of the Zenith system in the U.S.?
The Zenith system holds FDA Premarket Approval (PMA P020018) for use in the United States. This approval confirms its compliance with rigorous safety and efficacy standards for endovascular treatment of abdominal aortic or aorto-iliac aneurysms. The device’s regulatory history is also documented in the FDA’s public database under the PMA number and product code (MIH).
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 | P020018 | Class III | Active |
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Manufacturer
- Manufacturer
- Cook, Inc.
Sources (1)
- FDA PMA P020018 24 fields · synced Oct 6, 2026