DURHAM, N.C., July 22, 2015 /PRNewswire/ -- Micell Technologies, Inc. has begun enrolling patients in DESSOLVE C: a prospective, single-blind, multi-center, randomized, controlled clinical trial to demonstrate the efficacy and safety of its MiStent SES® Sirolimus Eluting Absorbable Polymer Coronary Stent System. MiStent SES is used to treat patients with coronary artery disease, and its performance will be compared, in this study, to TIVOLI Bioabsorbable Polymer Based Sirolimus-Eluting Stent. Professor Ya-Ling Han, M.D., Vice President of the General Hospital of Shenyang Military Region, is the principal investigator. Xu Bo, M.B.B.S., Director of the Catheterization Laboratory at the National Center for Cardiovascular Diseases and Fu Wai Hospital, and Yang Yuejin, M.D., Ph.D., Vice President of the Cardiovascular Institute and Fu Wai Hospital are co-principal investigators. DESSOLVE C, intended to support regulatory approval of MiStent SES in China, is being sponsored by Hefei Life Science Technology Co., Ltd. in conjunction with Micell.
The primary endpoint for this trial is nine-month in-stent late lumen loss. The study will compare nine-month angiographic and 12-month clinical outcomes between MiStent SES and TIVOLI, a locally-favored bioabsorbable coated stent developed in China. Candidates for trial participation suffer from symptomatic coronary artery disease, including those with chronic stable angina, silent ischemia, acute coronary syndromes and those who qualify for percutaneous coronary interventions. Enrollment is expected to include about 428 patients randomized to MiStent SES or TIVOLI at approximately 18 clinical sites within China.
An angiographic sub-study will evaluate the degree of late lumen loss progression at three years post-procedure. The sub-study data are intended to confirm a finding in the preceding MiStent SES First-in-Human study, that MiStent SES has a significant reduction in the degree of late lumen loss progression in contrast to what has been demonstrated in other drug-eluting stents.
"We are very excited about starting the randomized, controlled study in China and working with Micell to bring MiStent SES to the Chinese market," said Professor Han. "MiStent SES is redefining drug-delivery to match vessel response, and will bring this valuable product to the Chinese patients to treat their coronary artery disease. Long-term outcomes, especially three-year angiographic follow-up will provide us very important information about the MiStent SES."
Arthur J. Benvenuto, Chairman and Chief Executive Officer of Micell said, "The morbidity and mortality of cardiovascular disease are continuing to increase, and pose a significant health risk, in China. As of 2011, there were about 230 million patients with cardiovascular disease, leading to 3 million deaths each year." Mr. Benvenuto continued, "Even given recent advancements in medicine and healthcare, patients could gain additional benefit from a new class of drug-eluting stent that allows the drug to remain in the diseased tissue for an extended period."
In connection with the study, MiStent SES will be distributed exclusively by Hefei in China, Hong Kong and Macau. MiStent SES has received CE Mark in the European Union, and already is available there through Micell's partner, STENTYS. STENTYS introduced MiStent SES earlier this year to Western Europe via a controlled launch, which will be followed by a full commercial launch in the second half of 2015 in selected countries within Europe, the Middle East, South-East Asia and Latin America.
About the MiStent SES
MiStent SES® is designed to optimize healing in patients with coronary artery disease. The rapidly absorbable coating of the MiStent SES, which contains crystalline drug (sirolimus) and an absorbable polymer, is intended to precisely and consistently provide for local drug delivery and limit the duration of polymer exposure. These characteristics potentially reduce the safety risks associated with currently commercially available 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 SES leverages the benefits of a cobalt chromium coronary stent system, a state-of-the-art, thin-strut, bare-metal stent, which has demonstrated excellent deliverability, conformability and flexibility.
EU approval of MiStent SES was supported by clinical data from two studies, DESSOLVE I and II. DESSOLVE II demonstrated superior in-stent late lumen loss rates and an excellent safety profile. Four-year DESSOLVE II data will be presented at TCT inOctober 2015. The three-year follow-up of the DESSOLVE clinical studies subjects was completed in 2014 and these patients continue to undergo long-term follow-up.
Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements that can be identified by the fact that they do not relate strictly to historical or current facts. Forward-looking statements include words such as "anticipates," "estimates," "expects," "projects," "intends," "plans," "believes" and words and terms of similar substance in connection with the results of a post-marketing clinical program and the commercialization and sale of the MiStent SES® in Europe, China and other markets. We caution readers that the forward-looking statements contained in this press release are predictions based on our current analysis of and expectations about future events and speak only as of the date of this press release. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, including, but not limited to the following: the results of any further clinical trials and studies; our ability to obtain regulatory approval of the MiStent SES in other jurisdictions; the successful development and commercialization of the MiStent SES in Europe, China and other markets; the ability of the MiStent SES to effectively and successfully compete with current commercially available drug-eluting stent technologies in Europe and other markets; and our ability to maintain and protect our proprietary stent coating technology. Actual results, performance or achievements could differ materially and adversely from those expressed or implied by any forward-looking statement contained in this press release.
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