Guidant’s SPIRIT
This article was originally published in The Gray Sheet
Executive Summary
Over 300 patients are enrolled in the SPIRIT II and SPIRIT III European drug-eluting stent clinical trials, triggering a $60 mil. milestone payment to drug-supplier Novartis, Guidant announces Sept. 21. The trial compares Guidant's Xience V everolimus-eluting stent to Boston Scientific's Taxus paclitaxel-eluting stent. In June, FDA approved an expansion of the SPIRIT III trial to include 1,292 patients at up to 80 sites (1"The Gray Sheet" Aug. 29, 2005, In Brief). The notified body that will review Xience for CE Mark completed its inspection of the firm's Temecula, Calif. facility...