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The Zenith AAA endovascular graft.
Amir Kaviani1, Roy K Greenberg
1The Cleveland Clinic Foundation, Department of Vascular Surgery, Cleveland, Ohio 44195, USA.
Expert Review of Medical Devices
|November 19, 2005
Summary
The Zenith endovascular graft effectively treats abdominal aortic aneurysms with low mortality and endoleak rates. Device integrity is high, with design improvements addressing rare issues like stent detachment.
Area of Science:
- Vascular Surgery
- Biomedical Engineering
- Medical Devices
Background:
- The Zenith endovascular graft is a prosthesis designed for treating infrarenal abdominal aortic aneurysms.
- It is constructed from stainless steel, self-expanding Z-stents, and polyester fabric, featuring a modular design for adaptability.
Purpose of the Study:
- To evaluate the performance and safety of the Zenith endovascular graft for abdominal aortic aneurysm repair.
- To assess aneurysm sac behavior and device integrity based on worldwide clinical experience.
Main Methods:
- A prospective study compared endovascular and open surgical repair patients.
- Data analysis included periprocedural mortality, endoleak rates, device migration, and aneurysm sac changes.
- Worldwide experience and device explants were reviewed for integrity issues.
Main Results:
- Periprocedural mortality was under 2% in eligible patients.
- Endoleak risk was 7.4% at 12 months and 5.4% at 24 months.
- No device migration was observed over 12 months; most aneurysms shrank, and growth was treatable. Device integrity issues were rare, with design modifications implemented for suprarenal stent detachment.
Conclusions:
- The Zenith endovascular graft demonstrates favorable performance and safety for abdominal aortic aneurysm repair.
- Long-term data indicate good device integrity and predictable aneurysm sac behavior.
- Design enhancements have further improved device reliability.