Preclinical results of a prosthetic, early-stick graft with functional endothelium.

PURPOSE

The purpose of this study was to evaluate the NanoVasc Vascular Graft in comparison with a marketed expanded polytetrafluoroethylene (ePTFE) graft, both in vitro and in vivo. The graft was evaluated for use as both a bypass and arteriovenous (AV) access graft. Early-stick capabilities and patency were the primary end points evaluated.

METHODS

Third party, independent laboratories completed mechanical testing, biocompatibility, and preclinical data collection. An ovine carotid artery interposition model and a canine femoral AV access model were used to evaluate 5-mm and 6-mm internal diameter sizes, respectively.

RESULTS

There was no statistical difference in either model between the NanoVasc and ePTFE grafts with respect to patency. Time to hemostasis after cannulation with a 16-gauge needle was achieved ~10 times faster with the NanoVasc graft (mean time 27 seconds) compared with ePTFE. Histological analysis demonstrated functional endothelialization (nitric oxide expression), positive wound healing (cellular infiltration into the wall of the graft), and hemocompatibility of the NanoVasc graft.

CONCLUSIONS

The NanoVasc Vascular Graft is a strong candidate as a bypass and AV access graft. Its early-stick capabilities and patency rates are an attractive feature in comparison with current AV access grafts.