DURHAM, N.C., June 29, 2011 /PRNewswire/ — Micell Technologies,
Inc. today announced that it has completed its review of the
scheduled four-month follow-up on the first 10 patients from the
DESSOLVE I first-in-human trial of the MiStent Drug-Eluting
Coronary Stent System (“MiStent DES”), an ultra-thin drug-eluting
stent distinguished by a rapid-absorbing drug/polymer coating
formulation. Based on results observed in the DESSOLVE I trial,
Micell has reduced the sample size in its DESSOLVE II CE Mark study
from 270 to 171 planned subjects.
DESSOLVE I, the first-in-human study of the MiStent DES
comprising 30 patients with documented stable or unstable angina
pectoris, completed enrollment earlier this year. The primary
endpoint is in-stent late lumen loss, 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 23 mm length stent.
Dennis J. Donohoe, M.D., Micell’s Chief Medical Advisor, said,
“Encouraging results in minimizing late lumen loss with the MiStent
DES in the DESSOLVE I trial has prompted us to reduce the total
sample size of our pivotal DESSOLVE II trial, with the full
agreement of Micell’s clinical advisors and principal investigators
following rigorous data evaluation.”
The DESSOLVE II CE Mark trial is an ongoing 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.
“We believe that the MiStent DES could provide patients with
benefits greater than those offered by currently available
drug-eluting stents,” commented Arthur J. Benvenuto, Chairman and
Chief Executive Office
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