DURHAM, N.C., July 26, 2011 /PRNewswire/ — Micell Technologies,
Inc. today announced that it has completed patient enrollment in
its DESSOLVE II CE Mark clinical study of the MiStent®
Drug-Eluting Coronary Stent System. The MiStent DES is an
ultra-thin drug-eluting stent distinguished by a rapid-absorbing
drug/polymer coating formulation. Enrollment of 183 patients across
26 study centers throughout Europe and New Zealand was accomplished
ahead of schedule.
Micell previously announced that, based on results observed in
the DESSOLVE I first-in-human trial, the sample size in the
DESSOLVE II CE Mark study was reduced from 270 to 171 subjects.
“We believe that by exceeding the projected enrollment rate for
this study and completing enrollment in just 5 months,
participating clinicians have demonstrated their enthusiasm for the
novel MiStent drug-eluting stent,” commented Dennis J. Donohoe,
M.D., Micell’s Chief Medical Advisor. “We extend our gratitude to
the investigators and in particular the principal investigators of
the study, William Wijns, M.D. and John Ormiston, M.D., for their
support throughout the enrollment phase of this important
trial.”
The DESSOLVE II CE Mark trial is a multi-center study of
patients with documented stable or unstable angina pectoris. The
primary endpoint is superiority of the MiStent DES in minimizing
in-stent late lumen loss at nine months, compared to Medtronic’s
Endeavor® Sprint DES, as measured by the angiography core
laboratory in de novo lesions ranging in diameter from 2.5
to 3.5 mm and amenable to treatment with a maximum 30 mm length
stent.
Arthur J. Benvenuto, Chairman and Chief Executive Officer of
Micell, said, “The coating on the MiStent DES differs substantially
from those associated with commercially available DES technologies.
The coating is engineered to clear the stent within 45 to 60 days
and provide controlled and sustained delivery of sirolimus over a
period of months
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