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

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: Both bare and PLLA-coated MgBRFDs had excellent biocompatibility. The PLLA-coated MgBRFD has greater clinical feasibility because of its delayed bioresorption.