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Medtronic Drug-Eluting Stent Trial Aims For Equivalency, Approval In 2005

This article was originally published in The Gray Sheet

Executive Summary

Medtronic's U.S. pivotal study of its rapamycin analog-eluting stent will randomize patients to Johnson & Johnson/Cordis' siroliumus-eluting Cypher in the control arm

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American Heart Association Meeting In Brief

Taxus IV: Boston Scientific's Taxus paclitaxel-eluting stent is associated with a 3% MACE rate and 0.5% stent thrombosis according to complete 30-day safety data from the1,326-patient trial presented at the AHA annual meeting in Chicago Nov. 17. The company had presented data on 1,172 patients in September; however, the final 154 patients were considered more difficult to treat (1"The Gray Sheet" Sept. 30, 2002, p. 5). Also, 12-month follow-up results from the company's 61-patient Taxus I study of a slow-release paclitaxel-eluting stent showed zero restenosis and zero thrombosis at six months...

American Heart Association Meeting In Brief

Taxus IV: Boston Scientific's Taxus paclitaxel-eluting stent is associated with a 3% MACE rate and 0.5% stent thrombosis according to complete 30-day safety data from the1,326-patient trial presented at the AHA annual meeting in Chicago Nov. 17. The company had presented data on 1,172 patients in September; however, the final 154 patients were considered more difficult to treat (1"The Gray Sheet" Sept. 30, 2002, p. 5). Also, 12-month follow-up results from the company's 61-patient Taxus I study of a slow-release paclitaxel-eluting stent showed zero restenosis and zero thrombosis at six months...

Drug-Eluting Stent Trial Goals To Shift From Superiority To Equivalency – FDA

Future pivotal trials of drug-eluting stents should include both angiographic and clinical endpoints, and aim to demonstrate equivalency to previously approved drug-eluting stents, FDAers say

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