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In Brief: Johnson & Johnson Interventional Systems

This article was originally published in The Gray Sheet

Executive Summary

Johnson & Johnson Interventional Systems: Investigational device exemption application for JJIS heparin-coated coronary stent is expected to be filed with FDA before the end of 1995. The stent, which has active heparin "covalently bonded" to its surface, has been implanted in over 200 patients in Europe, JJIS President Marvin Woodall told analysts at the Piper Jaffray cardiology conference in New York City on Feb. 7. There have been no incidences of sub-acute thrombosis in the study, and six-month angiographic data from the first 50 patients in the trial shows a restenosis rate of 13%, Woodall noted. JJIS is the only company marketing a stent in the U.S. as an alternative treatment to balloon angioplasty. Palmaz-Schatz was approved in August for use in selected patients with coronary artery disease who are eligible for angioplasty ("The Gray Sheet" Aug. 8, 1994, p. 6)...



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