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In Brief: IsoStent, Inc.

This article was originally published in The Gray Sheet

Executive Summary

IsoStent, Inc.: First human implants of firm's radioisotope stent for the treatment of restenosis are completed by Tim Fischell, MD, at Borgess Hospital in Kalamazoo, Michigan. The implants are performed under a Phase I investigational device exemption approved by FDA in August. The Phase I trial will include 30 patients at three sites; patients will be evaluated for reduced restenosis following treatment for coronary artery disease. Stents used in the trial are radioactive versions of Johnson & Johnson's Palmaz-Schatz stent. San Carlos, California-based IsoStent expects enrollment to be complete by the end of the year...
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