FDAnews
www.fdanews.com/articles/73596-guidant-begins-spirit-iii-trial-enrollment-in-u-s

GUIDANT BEGINS SPIRIT III TRIAL ENROLLMENT IN U.S.

June 23, 2005

Guidant has begun enrollment in its SPIRIT III drug-eluting stent clinical trial, designed to evaluate the safety and efficacy of the company's Xience V stent compared to Boston Scientific's Taxus Express2 Paclitaxel-Eluting Coronary Stent System for the treatment of coronary artery disease.

Results of the large-scale pivotal SPIRIT III clinical trial may be used to obtain FDA approval for Xience V — an everolimus-eluting coronary stent system utilizing Guidant's cobalt chromium Multi-Link Vision Coronary Stent System platform — for the treatment of coronary artery disease. Guidant said it also anticipates initiating its SPIRIT II clinical trial in Europe in the very near future.

Guidant already has a presence in the U.S. drug-eluting stent field. Through a February 2004 agreement with Johnson & Johnson subsidiary Cordis, Guidant copromotes Cordis' Cypher Sirolimus-Eluting Coronary Stent in the U.S.