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J Am Heart Assoc. 2019 Oct 15;8(20):e014074. doi: 10.1161/JAHA.119.014074. Epub 2019 Oct 4.

Biodegradable Flow Diverter for the Treatment of Intracranial Aneurysms: A Pilot Study Using a Rabbit Aneurysm Model.

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Department of Neurosurgery Kyoto University Graduate School of Medicine Kyoto Japan.
Department of Neurosurgery Fukui Red Cross Hospital Fukui Japan.
Department of Neurosurgery Shizuoka General Hospital Shizuoka Japan.
Department of Biomedical Statistics and Bioinformatics Kyoto University Graduate School of Medicine Kyoto Japan.


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.


aneurysm; biodegradable polymer; endovascular treatment; flow diverter; stent

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