Micell Technologies Announces Presentation of Clinical Data at TCT 2011
Published: Nov 02, 2011
DURHAM, N.C., Nov. 2, 2011 /PRNewswire/ -- Micell Technologies, Inc. today announced that it has completed a preliminary analysis of data from the first-in-human clinical study, DESSOLVE I, of the MiStent® Sirolimus Drug Eluting Coronary Stent System, a thin drug-eluting stent distinguished by a rapid-absorbing drug/polymer coating formulation that is designed for controlled drug release. Four, six and eight month data will be presented at the Transcatheter Cardiovascular Therapeutics Conference (TCT 2011) in San Francisco, CA.
The presentation will be given in a Scientific Session, "Next Generation Drug-Eluting Stents and Bioabsorbable Scaffolds: Session II - Representative DES with Bioresorbable Polymers," on Tuesday, November 8 at 12:15 p.m. PST. Results will be presented by John Ormiston, M.D., Interventional Cardiologist with the Auckland Heart Group and Medical Director at Mercy Angiography in Auckland, New Zealand. William Wijns, M.D., Interventional Cardiologist with the Cardiovascular Center, Aalst, Belgium, and John Ormiston, M.D. are principal investigators for the study.
In the DESSOLVE I clinical trial, the MiStent DES was used to treat 30 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. The study was performed in five centers in New Zealand, Australia and Belgium. This trial focused on evaluating the efficacy of the MiStent DES, and examined three independent groups of 10 patients using angiography, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) at four, six and eight months to evaluate the rate of in-stent late lumen loss (LLL) and the extent of tissue coverage of the stent at each time point.
Micell Technologies currently is conducting a second trial of the MiStent DES, DESSOLVE II; a prospective, single-blind, unbalanced randomized, controlled, multicenter superiority trial in Europe, Australia and New Zealand. This trial completed enrollment in July 2011 with 183 patients enrolled.
About the MiStent DES
The MiStent Sirolimus 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 being evaluated in international clinical studies and patient enrollment is complete in those studies.
The MiStent Sirolimus 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 associated with 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.
Contact: Micell Technologies
Arthur J. Benvenuto, Chairman & CEO
SOURCE Micell Technologies, Inc.