Evaluation of a Novel Endoluminal Vascular Occlusion Device in a Porcine Model: Early and Late Follow-up

Abstract

Purpose:

To evaluate the efficacy of a new vascular occlusion device (VOD) in a preclinical controlled study versus embolization coils.

Methods:

The Biomerix VOD was made from a biodurable porous polyurethane matrix in the shape of a cylinder measuring 1.5 cm long by 6.0 mm wide. Thirty-three swine were selected to undergo embolization of a 3 to 5-mm-diameter iliac artery using either a single VOD (27 animals) or sufficient Cook fibered stainless steel coils to achieve angiographic occlusion (6 controls). Test animals were assigned to undergo angiography at 1 week (n = 11), 1 month (n=6), 3 months (n=6), or 6 months (n=4). Two control animals were assigned to angiographic follow-up at 1 week, 1 month, and 3 months. Test and control animals were euthanized at each time point to explant occluded vessels for histological analysis. Study endpoints were device utilization, time to occlusion, postdeployment migration, and persistent angiographic occlusion at 7, 30, 90, and 180 days.

Results:

One VOD was deployed in each test animal, whereas a mean 3.3±0.8 coils were needed to achieve angiographic occlusion in the 6 controls (p < 0.001). The time to occlusion was significantly shorter with the VOD (1.46±0.73 versus 5.83±1.60 minutes for the coils; p < 0.001). There was no evidence of recanalization or filling defects at the site of VOD deployment, while filling defects were seen in 3 of 6 coil-treated controls. The VOD arm showed superior angiographic occlusion versus coils at the 1-week, 1-month, and 3-month angiographic follow-up time points. Histological evaluation showed that the VOD was equivalent to the embolization coils at the 1-week (n = 6) and 1-month (n=6) endpoint (100% luminal occlusion). In the 3-month group (n=6), the VOD showed 95% to 100% luminal occlusion versus 90% to 95% in the control animals. In the 6-month group, VOD showed 85% to 95% occlusion.

Conclusions:

The Biomerix VOD appears highly effective and reliable, resulting in significantly faster and longer lasting occlusion compared with fibered stainless steel embolization coils.