Medtronic Endeavor DES 4-Month Data Bode Well For Pivotal Studies – Firm
This article was originally published in The Gray Sheet
Executive Summary
Medtronic is taking heart from Boston Scientific's TAXUS IV paclitaxel-eluting stent study results indicating that a late lumen loss of 0.39 mm in-stent was associated with an 8% restenosis rate
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Endeavor DES: Medtronic is on track to file IDE for Endeavor III confirmatory study in the "next few weeks and begin [a] study here in the U.S. in late December," Medtronic CEO Art Collins tells investors Nov. 12, during a quarterly earnings call. The Endeavor II pivotal trial has crossed its midway point, with 600 of 1200 patients enrolled, the exec also notes, commenting that safety and toxicity data for the firm's ABT-578 drug compound are favorable. Medtronic continues to forecast a European DES launch in late 2004 and a U.S. release at the end of 2005 (1"The Gray Sheet" September 22, 2003, p. 8)....