DURHAM, N.C., July 26, 2011 /PRNewswire/ -- Micell Technologies, Inc. today announced that it has completed patient enrollment in its DESSOLVE II CE Mark clinical study of the MiStent® Drug-Eluting Coronary Stent System. The MiStent DES is an ultra-thin drug-eluting stent distinguished by a rapid-absorbing drug/polymer coating formulation. Enrollment of 183 patients across 26 study centers throughout Europe and New Zealand was accomplished ahead of schedule.
Micell previously announced that, based on results observed in the DESSOLVE I first-in-human trial, the sample size in the DESSOLVE II CE Mark study was reduced from 270 to 171 subjects.
"We believe that by exceeding the projected enrollment rate for this study and completing enrollment in just 5 months, participating clinicians have demonstrated their enthusiasm for the novel MiStent drug-eluting stent," commented Dennis J. Donohoe, M.D., Micell's Chief Medical Advisor. "We extend our gratitude to the investigators and in particular the principal investigators of the study, William Wijns, M.D. and John Ormiston, M.D., for their support throughout the enrollment phase of this important trial."
The DESSOLVE II CE Mark trial is a 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.
Arthur J. Benvenuto, Chairman and Chief Executive Officer of Micell, said, "The coating on the MiStent DES differs substantially from those associated with commercially available DES technologies. The coating is engineered to clear the stent within 45 to 60 days and provide controlled and sustained delivery of sirolimus over a period of months, while limiting vascular exposure to the polymer coating to less than 90 days. As a result, we expect the MiStent DES could optimize sirolimus therapy by reducing the risk of complications such as late stent thrombosis, while suppressing neointimal hyperplasia and related healing responses to arterial injury that lead to restenosis."
About the MiStent DES
The MiStent Drug-Eluting Coronary Stent System is designed to optimize healing in patients with coronary artery disease. Micell's rapid-absorbing drug/polymer formulation is intended to precisely and consistently control drug elution and polymer exposure duration to reduce the safety risks associated with current commercially available drug-eluting stent technologies.
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 is currently 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 registered trademarks of Micell Technologies, Inc.