REPOSITIONABLE VASCULAR OCCLUDER - EXPERIMENTAL COMPARISON WITH STANDARD GIANTURCO COILS

PURPOSE: To evaluate the efficacy and recanalization rates of a newly designed vascular occlusion device. MATERIALS AND METHODS: The self-ex panding vascular occluder was braided from fine nitinol wires and fill ed with polyester fibers. The device was delivered through a 6-F polye thylene introducing sheath with use of a delivery cable with a microsc rew adaptor. Comparison was made between one occlusion plug and two Gi anturco coils placed in the corresponding contralateral arterial segme nt in nine dogs and six pigs. The mean diameter of the targeted vessel s was 4.8 mm +/- 0.8. Two animals were killed immediately after occlus ion, and the remaining 13 animals underwent follow-up angiography at 1 week and/or 1 month, after which the animals were killed and the vess els were explanted for gross and histopathologic examination. RESULTS: Significantly shorter time-to-occlusion was achieved with the nitinol plug compared with two Gianturco coils (1.73 minutes +/- 1.28 vs 5.73 minutes +/- 6.18; P = .021). The recanalization rate at 1 month was a lso significantly lower (36.4% vs 81.8%, P = .027). The occlusion time was strongly dependent on the target artery diameter with Gianturco c oils (R = .79, P = .0007), and not with the nitinol plug. CONCLUSION: The nitinol vascular occluder appears highly effective and reliable, w ith one plug resulting in significantly faster and longer lasting occl usions compared with two Gianturco coils. The new device can be reposi tioned prior to release, therefore allowing optimal positioning.