Micell Technologies, Inc. today announced that a peer reviewed article discussing imaging and clinical results of the DESSOLVE I trial of its MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES®) was accepted for publication on the JACC Cardiovascular Interventions website. The paper, "First-in-Human Evaluation of a Bioabsorbable Polymer-Coated Sirolimus-Eluting Stent: Imaging and Clinical Results of the DESSOLVE I Trial (DES With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesion in the Native Coronary Arteries)", is planned to also appear in the October 2013 issue of JACC Cardiovascular Interventions.
The article concluded that, upon 18 months' follow-up, the MiStent SES -- an absorbable polymer-coated, cobalt chromium, sirolimus-eluting stent -- was associated with a low and stable in-stent late lumen loss, complete strut coverage, and no stent thrombosis. Authors of this paper included co-principal investigators for the DESSOLVE I trial, William Wijns, M.D., Ph.D., of the Cardiovascular Center, Aalst, Belgium and John Ormiston, M.B.Ch.B., of the Mercy Angiography Unit, Auckland, New Zealand.
Data included in this paper also will be the subject of a presentation by John Ormiston, M.B.Ch.B. at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium to be held in San Francisco, October 27 - November 1, 2013.
About The Journal of the American College of Cardiology's "Online Before Print""Online before print" manuscripts are accepted, peer reviewed articles that have been accepted for publication ahead of being assigned an issue date. Manuscripts may be subject to additional copyediting that could affect content before being published in the October 2013 issue.
About the MiStent SES
The MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES®) is designed to optimize healing in patients with coronary artery disease. MiStent's rapidly absorbable coating is intended to precisely and consistently control drug elution and limit polymer exposure duration to reduce the safety risks associated with current commercially available drug-eluting stent technologies.
The innovative MiStent SES system includes a proprietary stent coating that contains crystalline drug (sirolimus) and an absorbable polymer. The coating provides controlled and sustained release of therapeutic levels of drug as the polymer softens and disperses from the stent into the adjacent tissue. These properties are intended to enhance safety as compared to conventional permanent polymer DES.
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 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.
Results of animal studies have determined that the coating is cleared from the stent in 45 to 60 days leaving a bare metal stent and the polymer is completely absorbed into the surrounding tissue within 90 days to promote long-term patency and compatibility with the artery.
Micell was granted CE (Conformite Europeenne) Mark approval for MiStent SES for the European Economic Union in June 2013, but is not approved in the United States or any other countries. A two year follow-up of DESSOLVE I and II clinical studies subjects was completed in 2013, and they currently are undergoing long-term follow-up.
About DESSOLVE I and DESSOLVE II Studies
The DESSOLVE I trial, the first clinical assessment of safety and efficacy of the investigational MiStent SES, treated thirty 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. Subjects were enrolled across five study centers in New Zealand, Australia and Belgium. Three independent subgroups of 10 patients each were evaluated using angiography, IVUS and OCT at three time points: four, six and eight months. The primary efficacy endpoint was in-stent late lumen loss. Safety was assessed by incidence of MACE and presence of strut coverage with tissue within the treated artery at each time point. William Wijns, M.D., Ph.D., Cardiovascular Center, Aalst, Belgium and John Ormiston, M.B.Ch.B., Mercy Angiography Unit, Auckland, New Zealand are co-principal investigators for this trial.
The DESSOLVE II CE (Conformite Europeenne) Mark trial is a randomized, multi-center study of patients with documented stable or unstable angina pectoris. The primary endpoint is superiority of the MiStent SES® in minimizing in-stent late lumen loss at nine months, compared to Medtronic's Endeavor® Sprint DES, as measured by an independent angiography core laboratory in de novo coronary lesions in vessels ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 30 mm length stent. The DESSOLVE II study completed enrollment of 184 patients in July 2011. Data analysis confirms that DESSOLVE II met all study objectives, demonstrated a competitive in-stent late lumen loss, and achieved strong signal of safety.