Nitinol intravascular stent: results of preclinical evaluation.

PURPOSE

To test an expandable nitinol intraluminal stent for hoop strength, biocompatibility, corrosion resistance, and patency.

MATERIALS AND METHODS

Forty-four stents were implanted in the iliac arteries of 22 sheep. Follow-up was performed with angiography and histologic examination for up to 6 months.

RESULTS

All but one stent remained widely patent during the follow-up period. Two stents in two sheep were placed incorrectly early in the study; these sheep were not followed up. Hoop strength was found to be superior to that of a similar, commercially available, self-expanding stent. Minimal corrosion was seen at 6 months, and the stent appears to be biocompatible. The stent has good radiopacity and deploys with minimal foreshortening.

CONCLUSION

The stent can be reliably and safely deployed in the vascular system. Clinical trials in humans are warranted.