Micell Technologies Announces Reduced Clinical Trial Sample Size for MiStent® Drug-Eluting Coronary Stent Based on Early Clinical Data
Published: Jun 29, 2011
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 Officer of Micell. "Furthermore, results from our comprehensive ongoing preclinical program give us confidence that the MiStent DES also will be highly differentiated from the next generation of absorbable products under development."
Updated information on the DESSOLVE II trial will be provided at ClinicalTrials.gov.
About the MiStent DES
The MiStent DES is a drug-eluting stent designed to optimize healing. Micell's rapid-absorbing drug/polymer formulation is intended to precisely and consistently control drug elution and polymer exposure duration. The MiStent DES is intended to deliver a precise therapeutic solution for coronary artery disease with the potential to avoid the long-term safety concerns associated with current drug-eluting stents.
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 DES leverages the benefits of Eurocor's (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. GLP pre-clinical trials have shown that the drug/polymer coating is eliminated from the MiStent DES within 45 to 60 days. In addition, the polymer-based coating is fully absorbed in tissue by 90 days in vivo, at which point the bare-metal stent remains. The MiStent DES currently is being evaluated in international clinical studies.
The MiStent Drug-Eluting Coronary Stent System is an investigational device. It is not yet approved or available for sale in any market.
About Micell Technologies Inc.
Micell Technologies is a biomedical company that is enhancing the performance of medical devices with innovative drug-delivery systems. Its unique surface and polymer modification technologies enable Micell to precisely and consistently control drug elution and polymer exposure duration, creating the potential for a therapeutic solution to coronary artery disease without the long-term safety concerns of currently available drug-eluting stents. Micell also is developing a drug-coated balloon for vascular interventions. Visit us at www.micell.com.
Micell, Micell Technologies, the Micell Logo, and MiStent are among the trademarks of Micell Technologies, Inc.
Contact: Micell Technologies
Arthur J. Benvenuto, Chairman & CEO
SOURCE Micell Technologies, Inc.