| TAXUS VI.
In December 2002, we completed enrollment of our TAXUS VI clinical
trial. TAXUS VI is an international trial studying 448 patients
with complex coronary artery disease at 44 sites. It is designed
to establish the safety and efficacy of the moderate-release formulation
in the treatment of longer lesions. The trial – which includes
the use of multiple stents – has a primary endpoint based
on nine-month target vessel revascularization. This study is currently
at 30-day follow-up.
WISDOM. The Company has initiated
a transitional registry program (WISDOM) in a number of countries
as part of a limited commercial launch. This international, multi-center,
prospective, observational registry is collecting and analyzing
real-world data. A registry program enlists large numbers of clinicians
to document the performance of a specific therapy for a particular
disease or condition. This registry has enrolled more than 300 patients.
Milestone II. The Company expects
to begin a post-approval European registry shortly. The registry
is targeting 100 sites and plans to enroll 2000 patients to study
real-world usage patterns.
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