Abstract
Background Herein, we report an in vivo study of a biodegradable flow diverter (BDFD) for aneurysm occlusion. Conceptually, BDFDs induce a temporal flow-diverting effect and provide a vascular scaffold for neointimal formation at the neck of the aneurysm until occlusion. This offers several potential advantages, including a reduced risk of remote ischemic complications and more treatment options in case of device failure to occlude the aneurysm. Methods and Results A BDFD consisting of 48 poly-l-lactic acid wires with radiopaque markers at both ends was prepared. An in vitro degradation test of the BDFD was performed. Thirty-six BDFDs were implanted in a rabbit aneurysm model. Digital angiography, optical coherence tomography, histopathology, and scanning electron microscopy were performed after 1, 3, and 6 months, and 1 year. The in vitro degradation test showed that the BDFD was almost degraded in 1.5 years. In the in vivo experiment, aneurysm occlusion rates were 0% at 1 month, 20% at 3 months, 50% at 6 months, and 33% at 1 year. Optical coherence tomography showed that luminal area stenosis was the highest at 3 months (16%) and decreased afterward. Immunohistochemical analysis showed that more than half of the luminal surface area was covered by endothelial cells at 1 month. Device fragmentation was not observed in any lesions. Conclusions This first in vivo study of a BDFD shows the feasibility of using BDFDs for treating aneurysms; however, a longer follow-up is required for comprehensive evaluation of the biological and mechanical behavior peculiar to biodegradable devices.