Evaluation of the Nfocus LUNA, a new parent vessel occlusion device: a comparative study in a canine model.

BACKGROUND

Parent artery occlusion is sometimes required to treat cerebrovascular lesions.

OBJECTIVE

We evaluated the Nfocus LUNA parent vessel occlusion (PVO) device in comparison with the Vascular Plug (AVP) used in the peripheral vasculature for large-vessel occlusion in a canine animal model.

METHODS

The subclavian arteries were targeted for occlusion in 7 canines. Each animal received 1 LUNA and 1 AVP device sequentially rotated between the left and right subclavian arteries. Angiographic assessment was performed serially after device placement until vessel occlusion was observed and then again immediately before the animal was killed. Three animals were euthanized at 1 month and 4 at 2 months post-implantation, after which the native artery segments containing the implanted device were harvested and preserved for subsequent histological analysis.

RESULTS

The LUNA PVO device and the AVP were accurately positioned and deployed in all cases. Acute occlusion times for the devices were not statistically different. In no instance was there any evidence of device migration. At 28 and 55 days, the LUNA implants showed nearly complete occlusion with small recanalization channels, whereas the AVP devices were associated with low occlusion levels and large residual vascular channels within the occluder.

CONCLUSION

The LUNA PVO device and delivery system can be accurately placed to occlude vessels without migration and with a performance that is similar to the AVP. The LUNA PVO device on average provided a higher degree of occlusion durability at both 1 and 2 months.