FDAnews Device Daily Bulletin


Nov. 17, 2005

Guidant's experimental drug-coated stent performed better than an uncoated stent in a 12-month clinical trial of heart patients, the firm said.

Aiming to break into the lucrative drug-coated stent market, Guidant announced results of its Spirit First clinical trial, a prospective, randomized, single-blind trial evaluating Guidant's rapid-exchange Xience V Everolimus Eluting Coronary Stent System versus an uncoated Multi-Link Vision Coronary Stent System.

Boston Scientific and Johnson & Johnson are the only two devicemakers with drug eluting stents on the market.

The one-year data from the Spirit Frist trial continued to demonstrate the treatment effect of the Xience V Everolimus Eluting Coronary Stent System, with a highly statistically significant reduction of cell proliferation compared to the uncoated control, Guidant said.

At one year, the Xience V arm demonstrated an angiographic in-stent late loss of 0.23 mm and an in-segment late loss of 0.13 mm, which were 72 percent and 78 percent less, respectively, than the values of the uncoated control. The "late loss" indicator measures the width of a vessel immediately after stenting compared to a later date and predicts the likelihood of the artery reclogging. Other results from the trial found the rate of major adverse cardiac events was 15.4 percent for the Xience V arm, compared with 21.4 percent for the control.

"Everolimus has clearly proven its effectiveness in reducing tissue proliferation in the coronary vessels following stent implantation," said John Capek, president of vascular intervention at Guidant.