- Results continue to show excellent long-term safety and effectiveness -
DURHAM, N.C., Jan. 9, 2018 /CNW/ -- Micell Technologies, Inc. announced the recent online publication of five-year data from the DESSOLVE I and II trials. The report, "Long-term clinical outcomes of a crystalline sirolimus-eluting coronary stent with a fully bioabsorbable polymer coating: five-year outcomes from the DESSOLVE I and II trials" was peer reviewed and published by the editors of EuroIntervention and can be accessed on the publication website at MiStent 5-Year Results.
The goal of the two trials was to evaluate long-term clinical results for the MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent). Among the 148 MiStent patients who completed DESSOLVE I or DESSOLVE II, there were zero definite or probable stent thromboses noted through 5-year follow-up, demonstrating long-term safety. The combined study results demonstrated outstanding long-term effectiveness with a five-year Clinically-Driven Target Lesion Revascularization (CD-TLR) of 2.7%.
DESSOLVE I was a single-arm, first-in-human trial while DESSOLVE II was a 2:1 randomized trial comparing MiStent and the Endeavor® Sprint DES. Both studies included patients with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries with >50% diameter stenosis.
The corresponding author for the article is William Wijns, M.D., Ph.D., of The Lambe Institute for Translational Medicine at the National University of Ireland. Prof. Wijns noted, "We achieved greater than 95% 5-year follow-up for all DESSOLVE I and II patients. Across both studies, MiStent showed low rates of TLR, along with no definite or probable stent thrombosis."
Micell's chief medical advisor, Dennis Donohoe, M.D., commented, "With this additional publication, we continue to see consistent favorable results reported across multiple studies for MiStent, which is exciting for both clinicians and patients."
One-year results for the MiStent DESSOLVE III randomized trial were also recently published in The Lancet.
MiStent is designed to optimize clinical performance and healing 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.
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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Arthur J. Benvenuto, Chairman & CEO
SOURCE Micell Technologies, Inc.