DURHAM, N.C., Oct. 31, 2016 /PRNewswire/ -- Micell Technologies, Inc. (Micell) today announced that it presented five-year clinical safety and efficacy results from the DESSOLVE I and II trials of its MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent®). MiStent is designed to optimize vessel healing and long-term clinical performance in patients with coronary artery disease, and the presented data demonstrate sustained desirable clinical outcomes. These results were presented at the 28th Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference. TCT, the world's largest educational meeting focused on interventional cardiovascular medicine, is being held in Washington, D.C., October 29 – November 2.
In a session titled "Emerging Bioresorbable Polymer-Based Metallic DES", five-year results were presented from the DESSOLVE I and II clinical studies, which demonstrated a combined (DES I and II) target lesion revascularization (TLR) rate of 2.7% at five years. No probable or definite stent thromboses were reported in either study through five-year follow-up. David E. Kandzari, M.D., Director of Interventional Cardiology and Interventional Cardiology Research for Piedmont Heart Institute of Atlanta, Ga., made the presentation.
Dr. Kandzari commented, "These results from DESSOLVE I and II validate our initial hypothesis that MiStent's unique pharmacokinetic profile, with a rapidly absorbing polymer and extended elution of crystalline sirolimus, permits faster and stable vessel healing that translates to exceptional long-term outcomes."
Dean J. Kereiakes, M.D., Medical Director of The Christ Hospital Heart & Vascular Center and The Lindner Research Center, Cincinnati, Ohio, also presented data on the five-year results in a poster session. Dr. Kereiakes concluded, "This pooled analysis of patients treated with MiStent, which has a linear drug release and ultra-thin-strut, cobalt chromium stent design, suggests excellent long term safety and efficacy of this novel coronary stent."
Micell's patented supercritical fluid technology allows for a rigorously controlled coating of the drug and polymer, whereby the drug is applied to a bare-metal stent in a dry powder, crystalline form. This preserves its morphology and optimizes its pharmacokinetic (distribution and absorption) profile. MiStent also leverages the benefits of a cobalt chromium coronary stent system -- a state-of-the-art, ultra-thin-strut metallic stent that has demonstrated excellent deliverability, conformability and flexibility.
Dennis Donohoe, M.D., Micell's Chief Medical Advisor, remarked, "MiStent uniquely provides continued vascular drug delivery for nine months -- even after its bioresorbable polymer coating has been fully absorbed, which occurs over the course of 90 days." Dr. Donohoe continued, "Studies of MiStent to date have demonstrated a desirable lack of late lumen loss over 18 months, a characteristic that makes MiStent a clinically meaningful improvement in treating patients with coronary artery disease."
MiStent is designed to optimize healing and clinical performance in patients with coronary artery disease. The rapidly absorbable coating of MiStent, which contains crystalline drug (sirolimus) and an absorbable polymer, is intended to precisely and consistently provide for extended 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 and improve long-term clinical outcomes.
EU approval of MiStent was supported by clinical data from two studies, DESSOLVE I and II, which demonstrated superior in-stent late lumen loss rates and an excellent safety profile. Micell also completed enrollment in December 2015 of DESSOLVE III, a 1,400 patient, 20 center, randomized clinical trial comparing MiStent to Xience Everolimus Eluting Coronary Stent System® (Xience).
DESSOLVE III is a prospective, balanced, randomized, controlled, single-blind, multi-center study comparing clinical outcomes between MiStent and Xience in a "real world, all-comers" patient population. Patients in the trial suffered from symptomatic coronary artery disease, including those with chronic stable angina, silent ischemia, or acute coronary syndrome, and qualified for percutaneous coronary interventions. The primary endpoint for this trial is a non-inferiority comparison of target lesion failure (TLF) of the MiStent group versus the Xience group at 12 months post-procedure. The 12-month primary endpoint results for DESSOLVE III are expected to be released in the first half of 2017.
MiStent has received CE marking, but is not approved for sale in the United States.
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 MiStent in Europe 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 in other jurisdictions; the successful development and commercialization of MiStent in Europe and other markets; the ability of MiStent 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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SOURCE Micell Technologies