Abstract

Objective To investigate the performance and safety of domestic peripherally absorbable magnesium alloy stent. Methods Sixteen absorbable magnesium alloy stents were implanted in the bilateral iliac-femoral arteries of 8 Chinese Agricultural University minipigs selected randomly with computer.The mean weight was (21.19±1.93) kg. One pig was randomly selected by computer on 30th, 45th, 60th, 75th, 90th, 105th, 120th and 135th days after stent implantation and both stents were removed. The biochemical, imaging and histopathology index of the pig before and after stent placement were analyzed, t test was used to compare data collected before and after stenting. Results The biochemical index changes showed no statistical significance after stent implantation, the DSA indicated that vessel diameter was (4.39± 0.26) mm before stent implantation and (3.85±0.71) mm on the 30th to 135th day afterimplatation (t= 3.041, P= 0.008), the balance of vessel diameter before and after stenting ranged from 0 to 2.29 mm, with minimun on 30th day, and maximum on 90th day; HE and verhoeffvangieson showed significant stenosis of the arteries occurred on 60th, 90th and 120th day. From the 30th day to 135th day after stenting, the average diameter of residual lumen was (1.38±0.18) mm, the average area of residual lumen was (1.51±0.41) mm2, the average area of internal elastic lamina was (1.91±0.22) mm2, the average area of external elastic lamina was (4.79± 0.79) mm2, the average thickness of endothelium was (0.11±0.06) mm, the average area of new intima was (0.40±0.29) mm2, the average narrow area percentage was (21.96±16.48)%.The stent absorbed gradually, and not completely absorbed until 135th day after stenting. Endometrial cells completely covered stent surface, and the stent did not break or collapse at all. Conclusions The peripherally absorbable magnesium alloy stents is safe and effective in animal experiment. Application of this stent in human should be investigated with further studies. Key words: Iliac artery; Stents; Magnesium compounds; Graft occlusion, vascular; Animal experimentation

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