Magnesium-based bioresorbable flow diverter for intracranial aneurysms: a pilot study of biocompatibility and bioresorption in a rabbit vascular model.

Abstract

Bioresorbable flow diverters (BRFDs) have the potential to solve several problems associated with conventional permanent flow diverters. We have constructed bare and poly-L-lactic acid (PLLA)-coated magnesium BRFDs (MgBRFDs) using a high-strength corrosion-resistant magnesium alloy. This study aimed to compare bioresorption and biocompatibility between the two types in a rabbit vascular model to determine which is more clinically feasible in humans. Bare and PLLA-coated MgBRFDs were fabricated by braiding 48 thin magnesium alloy wires. Mechanical testing was conducted. Bare (n=13) and PLLA-coated (n=13) MgBRFDs were implanted into rabbit aortas and harvested 14, 30, and 90 days after implantation. The physical structure of the resolution process was examined using optical coherence tomography (OCT), micro-computed tomography, and scanning electron microscopy (SEM). The biological response of the vascular tissue was examined using SEM and histopathological analysis. The porosity and pore density of the bare MgBRFD were 64% and 16 pores/mm², respectively; corresponding values for the PLLA-coated MgBRFD were 63% and 12 pores/mm², respectively. The OCT attenuation score was significantly higher for the PLLA-coated MgBRFD at all time points (14 days, P=0.01; 30 days, P=0.02; 90 days, P=0.004). OCT, micro-computed tomography, and SEM demonstrated better stent structure preservation with the PLLA-coated MgBRFD. Neointimal thickness did not significantly change over time in either type of MgBRFD (bare, P=0.93; PLLA-coated, P=0.34); however, the number of inflammatory and proliferative cells peaked at 14 days and then decreased. Both bare and PLLA-coated MgBRFDs had excellent biocompatibility. The PLLA-coated MgBRFD has greater clinical feasibility because of its delayed bioresorption.