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Abbott to study Xience in women

This article was originally published in The Gray Sheet

Executive Summary

Firm will evaluate its Xience V everolimus-eluting coronary stent in 2,000 women beginning in mid-2007, Abbott says Feb. 6. The gender-specific study (SPIRIT WOMEN) is the first of its kind, according to the firm, and will enroll at 100 sites in Europe, Canada and Asia-Pacific and Latin American regions. Abbott also is planning a 3,000-patient, 100-site international SPIRIT V study, which will include both a registry of real-world patients and a randomized trial comparing Xience V to Boston Scientific's Taxus Liberté in diabetic patients. The latest trials will bring the number of patients studied in the SPIRIT series of six studies to 8,000, Abbott says. The firm, which launched Xience V internationally in October, hopes to gain FDA approval in the first half of 2008 (1"The Gray Sheet" Jan. 29, 2007, p. 8)...
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