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Mater Sci Eng C Mater Biol Appl. 2013 Apr 1;33(3):1355-60. doi: 10.1016/j.msec.2012.12.036. Epub 2012 Dec 13.

Safety and efficacy of nano lamellar TiN coatings on nitinol atrial septal defect occluders in vivo.

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1
Research Institute of Peking University in Shenzhen, Shenzhen 518057, China. Top5460@163.com

Abstract

Atrial septal defect (ASD) occlusion devices made of nickel-titanium (NiTi) have a major shortcoming in that they release nickel into the body. We modified NiTi occluders using Arc Ion Plating technology. Nano lamellar titanium-nitrogen (TiN) coatings were formed on the surfaces of the occluders. The safety and efficacy of the modified NiTi occluders were evaluated in animal model. The results showed that 38 out of 39 rams (97%) survived at the end of the experiment. Fibrous capsules formed on the surfaces of the devices. Gradual endothelialization took place through the attachment of endothelial progenitor cells from the blood and the migration of endothelial cells from adjacent endocardium. The neo-endocardium formed more quickly in the coated group than in the uncoated group, as indicated by the evaluation of the six month study group. After TiN coating, there was no significant difference in endothelial cell cycle. TiN coating significantly reduced the release of nickel in both in vivo and in vitro indicating an improved biocompatibility of the nitinol ASD occluders. Superior and modified ASD occluders may provide a good choice for people with nickel allergies after sFDA registration, which is expected in one to two years.

KEYWORDS:

Atrial septal defects (ASDs) occluders; Nano lamella; Nickel release; Nickel-titanium (NiTi); Safety and efficacy animal evaluation; TiN coating

PMID:
23827582
DOI:
10.1016/j.msec.2012.12.036
[Indexed for MEDLINE]
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