Navigation Links
Micell Technologies Announces Reduced Clinical Trial Sample Size for MiStent® Drug-Eluting Coronary Stent Based on Early Clinical Data
Date:6/29/2011

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
(919) 313-2104


'/>"/>
SOURCE Micell Technologies, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Micell Technologies Enrolls First Patient in CE Mark DESSOLVE II Study of MiStent™ Drug-Eluting Coronary Stent (DES)
2. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
3. King Pharmaceuticals and Palatin Technologies Delay Immediate Plans for Phase 3 Clinical Program With Bremelanotide for Erectile Dysfunction
4. Rockwell Medical Technologies, Inc. Begins Patient Enrollment for its SFP Dose-Ranging Study
5. Rockwell Medical Technologies, Inc. Begins Dosing Patients for SFP Phase IIb Clinical Study
6. New Clinical Studies Confirm Mauna Kea Technologies Cellvizio(R) GI in Range of Procedures
7. Palatin Technologies, Inc. Reports Initiation of Human Trials for the Treatment of Congestive Heart Failure
8. Emisphere Technologies, Inc. Announces 2007 Third Quarter Financial Results
9. Senesco Technologies Initiates Preclinical Studies for Cancer Target
10. ASEAN News: Epeius Biotechnologies Gains Commercial Approval for Rexin-G(R), a Tumor-Targeted Gene-Based Medicine for Metastatic Cancer
11. Epeius Biotechnologies Applauds the Belated Scholarship of Their Academic Contemporaries in 2007, As Targeted Gene Therapy Comes of Age in Clinical Medicine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/29/2017)... , Mar. 29, 2017 Research ... Navigation Systems Market 2014 - 2025" report to their ... ... reach USD 303.7 million by 2025. Increasing geriatric population prone ... demand for orthopedic navigation systems over the forecast period. Osteoarthritis ...
(Date:3/29/2017)... March 29, 2017  The Global Health Innovative ... partnership formed to battle infectious diseases around the ... million* that could help deliver a range of ... conditions. This latest round of ... clinical trial testing a pediatric formulation of a ...
(Date:3/29/2017)... BEACH, Calif. , March 29, 2017 /PRNewswire/ ... have recognized remote monitoring devices like  Soberlink Systems ...   The consensus paper, published in early 2017, ... practical and valuable in managing patient recovery." ... in the Journal of Addiction Medicine, detail a ...
Breaking Medicine Technology:
(Date:3/29/2017)... ... March 29, 2017 , ... Patients interested ... Carnegie, OK, from Dr. Jamie Cameron, with or without a referral. The FASTBRACES ... orthodontic treatment. Depending on each patient’s case, treatment with the FASTBRACES system could ...
(Date:3/29/2017)... ... 29, 2017 , ... Curio Wellness , a premium medical cannabis brand ... company’s executive management team with prominent executives from both inside and outside the cannabis ... Officer, Ted Dumbauld , who has more than twenty years of business leadership ...
(Date:3/29/2017)... ... March 29, 2017 , ... Hamlin Dental Group, multi-location dental office in ... dental treatments. Dental lasers are safe and effective options, and can be used alone ... improve the overall quality of care. , Dr. Hamid Reza of Hamlin Dental Group ...
(Date:3/29/2017)... ... ... VisualSP has helped over 1.5 million SharePoint users learn the content management system ... Help System for SharePoint was at the farm level. Enterprises using SharePoint Online in ... The company recently released a modified version of the Help System, VisualSP for Site ...
(Date:3/28/2017)... CARTERSVILLE, Georgia (PRWEB) , ... March 28, 2017 ... ... analyst to its award-winning team. Ruel Williamson brings his extensive knowledge of appraisals, ... been a leader in the real estate valuation industry for more than 40 ...
Breaking Medicine News(10 mins):