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Vascular occlusion with a balloon-expandable stent occluder
J G Moss1, J C Laborde, M C Clem
1Department of Cardiovascular and Interventional Radiology, University of Texas Health Science Center, San Antonio 78284.
Radiology
|May 1, 1994
Summary
A novel vascular occlusion device, featuring a silicone-sleeved stent, effectively and stably occludes vessels. This device achieved immediate and persistent occlusion in canine arteries and arteriovenous fistulas.
Area of Science:
- Vascular Surgery
- Medical Device Innovation
- Interventional Cardiology
Background:
- Vascular occlusion is crucial for managing various medical conditions, including arteriovenous fistulas and certain surgical interventions.
- Existing occlusion methods may present challenges in terms of stability, efficacy, and invasiveness.
Purpose of the Study:
- To assess the effectiveness and stability of a newly developed vascular occlusion device.
- To determine the device's capability in achieving immediate and sustained vascular occlusion.
Main Methods:
- A balloon-expandable stent coated with a silicone sleeve and a tapered nozzle was developed.
- The device was crimp-mounted on an angioplasty balloon catheter for delivery.
- Testing involved stability assessments under pulsatile pressure and occlusion efficacy in canine models.
Main Results:
- The device demonstrated excellent stability, with no migration observed at pulsatile pressures up to 300 mm Hg.
- Mean flow rate was significantly reduced from 443 mL/min to 1.9 mL/min post-occlusion.
- Immediate and persistent vascular occlusion was achieved in 12 canine arteries and six arteriovenous fistulas, confirmed by 3-month follow-up arteriography.
Conclusions:
- The novel vascular occlusion device provides immediate and stable vascular occlusion.
- The device shows promise for clinical applications requiring reliable and persistent vessel closure.