| Objective: To made and modify a new type pan-nitinol stainless steel buttom -removed ventricular septal defect (VSD) occluder and to evaluate its safety , efficiency and biocompabilities in animal experiment. Methods: The new device was transcatherly used in a canine ventricular septal defect model , and its nitinol materials were heat treated in three different temperature. Results: VSD models were transcatherly established in 9 of the 10 dogs, and VSDs in 8 dogs were transcatherly closed by the new-type occluders and its delivery cables without procedure related complications, while well epithelization and good biocompabilities were observed by gross, histological and SEM examinations. Oxide layer thickness and surface roughness increase as treated temperature lifted, 500C730min surface heat oxidation seemed optimazed the corrosion resistance behaviors and biocompability index, while 600C°/730min worsen most of them. Conclusion : The new devices and its delivery system were safe and efficient in animal experiment, and may fit for further clinic trials. And proper surface heat treat on nitinol might improve its biocompabilities.
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