DURHAM, N.C., May 11, 2011 /PRNewswire/ -- Micell Technologies, Inc. today announced that positive preclinical data will
In a porcine coronary model, data show continuous and controlled release of sirolimus, with the MiStent DES coating being eliminated from the stent within 45 to 60 days, and fully absorbed in the tissue by 90 days following implant. Preclinical studies additionally demonstrated a positive indication of safety with lower inflammation observed from the MiStent DES compared to the bare metal Abbott MULTI-LINK Vision™ Coronary Stent at 30 and 90 days in the challenging overlapping stents implant configuration.
James B. McClain, Ph.D., Senior Vice President of Micell, said, "Micell is uniting well-known DES stent components with a proprietary coating process to produce a fundamentally different DES. Our preclinical studies demonstrate a markedly consistent drug delivery profile with controlled, linear release of therapeutic levels of drug."
Clinical trials of the MiStent DES include DESSOLVE I, a study of 30 patients with documented stable or unstable angina pectoris or ischemia, which completed enrollment earlier this year. The primary endpoint is in-stent late lumen loss, 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. DESSOLVE II is an ongoing multi-center study of approximately 270 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® Sprint 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 30 mm long stent.
Elazer R. Edelman, M.D., Ph.D., commented, "The presented data, based on a thorough preclinical evaluation, validate the premise that Micell's unique coating process could produce a remarkable level of consistency and control in a drug-eluting stent." Dr. Edelman is the Thomas D. and Virginia W. Cabot Professor of Health Sciences and Technology at the Massachusetts Institute of Technology and is a consultant to Micell.
EuroPCR, Paris, France -- Wednesday, May 18, 15:00-16:30Plenary session: Cardiovascular Innovation Pipeline – Coronary Heart DiseaseMiStent DES: A Novel Third Generation DES with a Fully-absorbable Coating and Enhanced Drug Delivery CapabilitiesPresented by James B. McClain, Ph.D., Senior Vice President, Micell Technologies
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 TechnologiesArthur J. Benvenuto, Chairman & CEO(919) 313-2104
SOURCE Micell Technologies, Inc.
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