Vascular occlusion with a balloon-expandable stent occluder

PURPOSE: To evaluate the effectiveness of a new vascular occlusion device. MATERIALS AND METHODS: The device was created by coating a balloon-expandable stent with a silicone sleeve that tapers to a blind-ended nozzle at its leading end. Once crimp-mounted on an angioplasty balloon catheter, the device is introduced over a guide wire through a small end hole in the nozzle. RESULTS: The device was tested for stability and occlusive ability. No migration was measured over a pulsatile pulse range of 50-300 mm Hg, and mean flow rate in the occluded vessel was reduced from 443 mL/min ± 99 (standard deviation) to 1.9 mL/min ± 2.7. Subsequently, 12 arteries were occluded in three dogs, and immediate vascular occlusion was achieved in all vessels. An arteriovenous fistula was created in another six dogs and was successfully occluded with the device. Follow-up arteriography at 3 months demonstrated persistent occlusion with no migration of the device. CONCLUSION: This new occlusive device offers immediate vascular occlusion with excellent stability.