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www.fdanews.com/articles/74066-guidant-begins-enrollment-in-european-des-study

GUIDANT BEGINS ENROLLMENT IN EUROPEAN DES STUDY

July 7, 2005

Guidant has begun enrollment in its SPIRIT II drug-eluting stent (DES) clinical study, a 300-patient study evaluating its Xience V everolimus-eluting coronary stent system utilizing Guidant's cobalt chromium Multi-Link Vision coronary stent system platform.

The single-blind, randomized controlled study further evaluates the Xience V compared to Boston Scientific's Express2 paclitaxel-eluting coronary stent system for the treatment of coronary artery disease. Results of the SPIRIT II study will provide additional clinical data to support the launch of Xience V in several countries outside the U.S.

Guidant recently announced the U.S. initiation of SPIRIT III, a large-scale pivotal clinical trial evaluating Xience V, which may be used to obtain FDA approval for Xience V for the treatment of coronary artery disease.