Guidant releases one-year DES data
This article was originally published in The Gray Sheet
Executive Summary
Angiographic in-stent late loss and in-segment late loss with Guidant's Xience V everolimus-eluting stent are 72% and 78% lower than with Guidant's bare metal Multi-Link Vision, according to 12-month results from the firm's SPIRIT FIRST feasibility trial. Xience V showed a device-related major adverse cardiac event rate of 3.8% (1/26) compared with 21.4% (6/28) in the control arm. Xience V is also being measured against Boston Scientific's Taxus paclitaxel-eluting stent in two ongoing European trials (1"The Gray Sheet" Sept. 26, 2005, In Brief)...
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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...
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