VASCULAR STENT PROTOTYPE - IN-VIVO SWINE STUDIES

PURPOSE: Evaluation of implantation technique and biocompatibility of a new balloon-expandable peripheral vascular stent. MATERIALS AND METH ODS: Twenty-four stents, varying in diameter from 4 mm to 14 mm and le ngth from 2 cm to 6 cm, were placed in eight microswine, After implant ation, two of the animals were killed at 2 months and the remaining an imals were killed at 6 months, All animals underwent premorbid angiogr aphy. The stents were then pressure fixed, harvested, and encased in m ethacrylate. The specimens were then sectioned with a diamond saw prio r to staining. Individual specimens were then photographed, projected against a screen, and the neointimal thickness quantified by calibrati on with the diameter of the stent wire retained in the specimen. RESUL TS: Technical success (implantation) was 96% (one embolization), All s tents were widely patent at 2- and 6-month follow-up, Histopathologic examination demonstrated a very thin neointima covering the stent wire s, with a maximum thickness measuring 254 mu m. CONCLUSION: This new s tent is safely implantable and biocompatible as tested in the arterial system of this animal model, Human clinical trials are indicated.