Oral Presentations to Include New Long-Term Results from First-in-Human Study

DURHAM, N.C., /PRNewswire/ -- Micell Technologies, Inc. today announced the updated  three- and two-year clinical outcomes from its DESSOLVE I and II clinical trials, respectively, will be presented at the EuroPCR conference to be held in Paris, France from May 20 - 23. Two oral presentations will be made by William Wijns, M.D., Ph.D., Cardiovascular Center, Aalst, Belgium:
•DESSOLVE II Trial Results: Two-Year Follow-up of a Crystalline Sirolimus-Eluting Stent with Rapid Bioabsorbable Polymer. Wednesday, May 21, 2:40 p.m. CET.
•Long-Term Clinical Results from the DESSOLVE I First-In-Human Trial and the DESSOLVE II Randomised Trial of a Sirolimus-Eluting Stent with Fully Absorbable Polymer. Friday, May 23, 9:00 a.m. CET.

About the MiStent SES

The MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES®) is designed to optimize healing in patients with coronary artery disease. The rapidly absorbable coating of the MiStent SES is intended to precisely and consistently control drug elution and limit polymer exposure duration, thereby reducing the safety risks associated with current commercially available drug-eluting stent technologies.

The innovative MiStent SES system includes a proprietary stent coating that contains crystalline drug (sirolimus) and an absorbable polymer. The coating provides controlled and sustained release of therapeutic levels of drug as the polymer softens and disperses from the stent into the adjacent tissue. These properties are intended to enhance safety as compared to conventional permanent polymer DES.

Using an approved drug (sirolimus) and polymer (PLGA), Micell's patented supercritical fluid technology allows a rigorously controlled drug/polymer coating to be applied to a bare-metal stent. The MiStent SES leverages the benefits of the Eurocor (CE Marked) Genius® MAGIC Cobalt Chromium Coronary Stent System, a state-of-the-art bare-metal stent, which has demonstrated excellent deliverability, conformability, and flexibility.

Results of animal studies have determined that the coating is cleared from the stent in 45 to 60 days leaving a bare-metal stent, and the polymer is completely absorbed into the surrounding tissue within 90 days to promote long-term patency and compatibility with the artery.

Micell was granted CE (Conformite Europeenne) Mark approval for MiStent SES for the European Economic Union in June 2013; it is not approved in the United States or any other countries.  A two year follow-up of DESSOLVE I and II clinical studies' subjects was completed in 2013, and these patients currently are undergoing long-term follow-up.

About DESSOLVE I and DESSOLVE II Studies

The DESSOLVE I trial, the first clinical assessment of safety and efficacy of the MiStent SES®, 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 and all available patients at 18 months. The primary efficacy endpoint was in-stent late lumen loss. Safety was assessed by incidence of MACE and presence of strut coverage with tissue within the treated artery at each time point.

The DESSOLVE II CE (Conformite Europeenne) Mark trial is a randomized, multi-center study of patients with documented stable or unstable angina pectoris. The primary endpoint is superiority of the MiStent SES in minimizing in-stent late lumen loss at nine months, compared to Medtronic's Endeavor® Sprint DES, as measured by an independent angiography core laboratory in de novo coronary lesions in vessels ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 30 mm length stent. The DESSOLVE II study completed enrollment of 184 patients in July 2011. Data analysis confirms that DESSOLVE II met all study objectives, demonstrated a competitive in-stent late lumen loss, and achieved a strong signal of safety.

Source: Micell Technologies, Inc.