Vascular stent prototype: in vivo swine studies.
OBJECTIVE
Evaluation of implantation technique and biocompatibility of a new balloon-expandable peripheral vascular stent.


METHODS
Twenty-four stents, varying in diameter from 4 mm to 14 mm and length from 2 cm to 6 cm, were placed in eight microswine. After implantation, two of the animals were killed at 2 months and the remaining animals were killed at 6 months. All animals underwent premorbid angiography. The stents were then pressure fixed, harvested, and encased in methacrylate. The specimens were then sectioned by a diamond saw prior to staining. Individual specimens were then photographed, projected against a screen, and the neointimal thickness quantified by calibration with the diameter of the stent wire retained in the specimen.


RESULTS
Technical success (implantation) was 96% (one embolization). All stents were widely patent at 2- and 6-month follow-up. Histopathologic examination demonstrated a very thin neointima covering the stent wires, with a maximum thickness measuring 254 microns.


CONCLUSIONS
This new stent is safely implantable and biocompatible as tested in the arterial system of this animal model. Human clinical trials are indicated.
Fontaine
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AB
Department of Radiology, Ohio State University Medical Center, Columbus 43210, USA.
Dos Passos
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D000792:Angiography; D017130:Angioplasty / Q000295:instrumentation*; D000818:Animals; D001011:Aorta; D001158:Arteries / Q000473:pathology / Q000601:surgery*; D001672:Biocompatible Materials; D002339:Carotid Arteries; D005500:Follow-Up Studies; D015607:Stents; D013552:Swine; D013556:Swine, Miniature; D017539:Tunica Intima / Q000473:pathology
D001672:Biocompatible Materials