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In Brief: IsoStent

This article was originally published in The Gray Sheet

Executive Summary

IsoStent: Receives investigational device exemption from FDA Aug. 2 to begin Phase I clinicals of radioisotope-implanted versions of Johnson & Johnson's Palmaz-Schatz coronary stent for the treatment of restenosis. The 30-patient trial will be conducted at three clinical sites in the U.S., with patient follow up at one, six and 12 months, the San Carlos, California firm says. In addition, J&J purchases "an additional equity stake" in IsoStent "but remains a minority owner of the company." In April, the two firms announced an agreement under which J&J will provide R&D support to IsoStent as well as an initial minority investment ("The Gray Sheet" April 22, I&W-1). With the additional investment, J&J's Cordis subsidiary receives an option to exclusively market IsoStent products worldwide...

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