WEBSTER, Texas, June 2, 2011 /PRNewswire/ — IDEV Technologies,
Inc. (IDEV) today announced the completion of enrollment in the
SUPERB Trial, an FDA-approved IDE trial evaluating the use of
IDEV’s SUPERA® stent system for treatment of peripheral artery
disease in the superficial femoral artery (SFA). Enrollment
was completed in May, making SUPERB one of the fastest enrolling
SFA trials.
The trial is a prospective, single-arm study of 258 patients at
49 U.S. sites, led by national co-investigators Kenneth Rosenfield,
M.D., of Massachusetts General Hospital in Boston and Lawrence
Garcia, M.D., of Steward’s St. Elizabeth’s Medical Center of
Boston. The study objective is to demonstrate safety and
effectiveness of the SUPERA stent in treating obstructive disease
in the SFA.
Dr. Rosenfield summarized, “We are excited to complete
enrollment in this important trial, and will now focus our efforts
on patient follow-up and analysis. Given the encouraging data
we’ve seen from Europe for the SUPERA stent, and given the stent’s
outstanding mechanical properties, we are anxious to finalize our
results. It has been a pleasure to work with the great team of
researchers, coordinators, and support staff on this trial.”
“Endovascular treatment of the SFA in particular has been
problematic for the millions of patients suffering from PAD in the
United States,” added Dr. Garcia. “The unique radial strength
and flexibility of the SUPERA stent’s design may provide what has
been needed to successfully treat this challenging vessel.”
Dennis Donohoe, M.D., is IDEV’s Chief Medical Officer and has
served as a key liaison to the clinical site investigators
throughout the trial. “Completing enrollment of more than 250
pivotal patients in less than two years is a significant
achievement and reflects not only the caliber of our investigator
teams but also their confidence in this stent. I congratulate
the team and look forward
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