NATICK, Mass., Jan. 10, 2011 /PRNewswire/ — Boston Scientific
Corporation (NYSE:
BSX) today announced that it has completed enrollment in the
ORION clinical trial, which is designed to evaluate the Company’s
EPIC™ Self-Expanding Nitinol Stent System for the treatment
of iliac artery disease, a form of peripheral artery disease
associated with severe leg pain caused by insufficient blood flow
to the muscles (claudication). The trial will examine rates
of device- and/or procedure-related major adverse events and
patency rates at nine months in 125 patients at 28 sites in the
United States.
“We are pleased to complete the enrollment phase of this
important trial,” said Daniel Clair, M.D., F.A.C.S., Chairman of
the Department of Vascular Surgery, The Cleveland Clinic
Foundation, and Principal Investigator of the trial.
“Peripheral stenting has become a recognized standard in the
treatment of iliac artery disease, and the ORION trial will provide
important data on the performance of the EPIC Stent in treating
these types of lesions.”
The next-generation EPIC Stent is a self-expanding nitinol stent
designed to sustain vessel patency, while providing enhanced
visibility and accuracy during placement. It employs an
innovative Radial Tandem Architecture™, which is engineered
to provide stent flexibility while maintaining predictable radial
force characteristics across the entire stent size matrix.
The ORION trial incorporates stent diameter ranges from 6 to
12 mm and lengths up to 120 mm. All stent sizes are
compatible with 6F (2.1 mm) sheaths, and the stent delivery system
is compatible with 0.035 inch (0.89 mm) guidewires.
“We are encouraged by the success of our EPIC Stent since its
European approval and launch in early 2009, and we look forward to
its approval in the U.S. based on results from this trial,” said
Joe Fi
‘/>”/>
