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Endovascular aortic devices: the Parodi and Palmaz system
1Bowman Gray School of Medicine, Wake Forest University, Winston-Salem, NC, USA.
Surgical Technology International
|January 1, 1996
Summary
Early endovascular abdominal aortic aneurysm (AAA) treatments faced high failure rates. Prototypes showed inconsistent deployment, aortic injury, leakage, and thrombosis, hindering endovascular aneurysm repair development.
Area of Science:
- Vascular Surgery
- Biomedical Engineering
- Medical Device Development
Background:
- Endoluminal aneurysm exclusion concept explored for abdominal aortic aneurysm (AAA) treatment since 1976.
- Early endovascular strategies aimed to exclude AAA without open surgery.
Purpose of the Study:
- To describe the development and challenges of early endovascular treatment prototypes for AAA.
- To evaluate the feasibility and identify limitations of initial endovascular device designs.
Main Methods:
- Development of two distinct endovascular device prototypes for AAA.
- Testing of prototypes in canine aortas to assess deployment, sealing, and patency.
- Analysis of device-related complications including deployment inconsistencies, aortic injury, and thrombosis.
Main Results:
- First prototype (fabric graft on metallic cage) abandoned due to inconsistent cage deployment, leading to aortic injury or leakage and migration.
- Second prototype (Dacron graft on Silastic bag) resulted in prompt graft thrombosis in all experimental trials.
- Both prototypes demonstrated high failure rates, indicating significant technical challenges.
Conclusions:
- Early endovascular AAA repair attempts faced substantial technical hurdles.
- Device design and deployment mechanisms required significant refinement for successful AAA exclusion.
- These initial failures highlighted critical areas for future innovation in endovascular aneurysm repair.