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Micell Technologies Announces Positive Preliminary Data from DESSOLVE I Study of MiStent® Sirolimus Drug Eluting Coronary Stent System
Date:11/8/2011

in-stent late lumen loss of 0.03 mm at four months, 0.10 mm at six months and 0.08 mm at eight months follow-up with no binary restenosis or revascularizations. The mean in-stent late lumen loss values at four, six and eight months were 0.01, 0.21 and 0.09 mm, respectively. The mean and median values were comparable except at the six month time point, in which one patient experienced a high late loss value due to treatment of a highly calcified lesion and under-expansion of the stent. When data from this patient is excluded, the six month mean LLL is 0.10 mm. The median percent of stent struts covered by tissue was 96% at eight months, 97% at six months and 90% at four months per OCT analysis. IVUS confirmed good inhibition of neointimal hyperplasia. A MACE rate of 6.7%, including two non-Q wave myocardial infarctions (MI), one peri-procedural and one non-target vessel MI, was reported through eight months follow-up.

"The MiStent DES was designed to address a need for improved patient safety while providing equivalent or better efficacy as compared to currently available drug eluting stents," observed Dennis Donohoe, M.D., Chief Medical Advisor to Micell. "The excellent clinical outcomes of the DESSOLVE I trial demonstrate the value of the MiStent design in enabling elimination of drug and polymer from the stent in 45 to 60 days and providing patients the best of DES and BMS in one solution."

About DESSOLVE I and DESSOLVE II Studies

The DESSOLVE I trial, the first clinical assessment of safety and efficacy of the MiStent DES, treated thirty patients with de novo lesions in coronary arteries ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 23 mm length stent. Subjects were enrolled across five study centers in New Zealand, Australia and Belgium. Three independent subgroups of 10 patients each were evaluated using angiography, IVUS and OCT at three time points: four, six and eight months. The pr
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SOURCE Micell Technologies, Inc.
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