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

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. - Highlights: ► The nano lamella TiN coating did not change the shape-memory behavior and flexibility of the nitinol occluder. ► Nano lamella TiN coating modifications significantly reduced nickel release from nitinol ASD occluder. ► The new ASD occluder was found to be superior to nitinol ASD occluder with respect to both safety and efficacy