Micell Technologies(TM), Inc. announced it has enrolled the first patient in the DESSOLVE II (DES with Sirolimus and a bioabsorbable pOLymer for the treatment of patients with de noVo lEsions in the native coronary arteries) clinical trial. This clinical investigation is being conducted to support CE Mark approval of the company’s MiStent(TM) Drug-Eluting Coronary Stent System (MiStent DES).

The MiStent DES employs Micell’s proprietary supercritical fluid technology which applies a controlled absorbable polymer - sirolimus matrix onto a cobalt-chromium stent. In GLP preclinical trials, the drug completely elutes and the polymer is eliminated from the stent within 45 to 60 days in vivo, resulting in a bare-metal stent.

DESSOLVE II is a prospective, controlled, 2:1 unbalanced randomized, multi-center study of approximately 270 patients. Patients will be enrolled at 26 clinical sites in Europe, New Zealand and Australia. Candidates for the trial are patients with documented stable or unstable angina pectoris or ischemia. The primary endpoint is superiority of MiStent DES in minimizing in-stent late lumen loss at nine months, compared to Medtronic’s Endeavor® DES, as measured with angiography in treated de novo lesions ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 23 mm long stent.

Source:

Micell Technologies, Inc.