Positive Study Results for MiStent SES Drug/Absorbable Polymer Combo

Companies are forever pointing us at new clinical data supporting their technologies and devices. We tend to ignore much of the fluff that gets peddled, with the odd exception. One such is Micell Technologies, Inc., which we’ve been following for a couple of years now, ever since we spotted its approach of using a rapid absorbing polymer, in combination with an eluting drug, a combination which seems to confer on the MiStent SES coronary stent an unerring ability to prevent late lumen loss.

Background

The MiStent SES is a thin-strut drug-eluting stent with a bioabsorbable polymer developed to optimize vessel healing in patients with coronary artery disease. The mechanism of action is a unique drug delivery profile with three times longer drug presence versus absorbable polymer. Following elimination of the polymer in 90 days, the anti-proliferative effects of sirolimus continue to be delivered to the artery for up to nine months. Although several current bioabsorbable DES also report drug delivery for up to nine months or more, the MiStent SES’ capability to continue drug delivery in the absence of potential inflammatory-causing polymers is distinctive in this generation of DES with bioabsorbable coatings.

Micell is trumpeting long-term clinical outcomes from the DESSOLVE I and II clinical trials, presented at last month’s Cardiovascular Research Technologies (CRT) Conference in Washington. The data presentation, “MiStent SES Clinical Program: DESSOLVE I and II Trials 2-Year Follow-up” was delivered by Alexandra Lansky, M.D., Director, Interventional Cardiovascular Research and Angiography Core Laboratory Services with the Yale University School of Medicine, New Haven, Conn.

The DESSOLVE I trial demonstrated minimal progression of late lumen loss between eight and 18 months follow-up, with no target lesion MACE events through two years. The DESSOLVE II randomized trial two-year MACE rate was 6.7% for MiStent and 13.3% for the Endeavor DES control group. There were no probable or definite stent thromboses related to MiStent SES use in either trial through two years. Detailed serial IVUS, angiographic, and OCT imaging through 18 months in DESSOLVE I and angiographic and OCT imaging in conjunction with endothelial function testing in DESSOLVE II demonstrated excellent healing, effective suppression of neointimal hyperplasia with maintenance of normal endothelial function, and a sustained safety profile.

Investigator comments

Dr. Lansky commented, “MiStent SES is the only product in its class to optimize local drug delivery properties by providing up to nine months of drug presence with only three months for polymer absorption. The rapid elimination of the polymer with the sustained anti-inflammatory and anti-restenotic drug six months beyond the presence of the polymer was designed to allow normal healing while providing effective suppression of neointimal hyperplasia. Detailed imaging by IVUS, OCT and angiography extending from four to 18 months post-stent implantation confirmed desirable bare-metal stent-like healing.”

Elazer Edelman, M.D., a Thomas D. and Virginia W. Cabot Professor of Health Sciences and Technology at Massachusetts Institute of Technology, Professor of Medicine at Harvard Medical School and Senior Attending Physician in the Coronary Care Unit at the Brigham and Women’s Hospital in Boston, and a consultant to Micell added, “MiStent SES provides an exciting new level of consistency and performance for drug-eluting stents. Detailed tissue evaluations in animal studies, extensive imaging studies in both pre-clinical and clinical settings and two-year clinical data from the DESSOLVE clinical trial program correlate with each other to support a normal tissue healing process.”

Source: Micell Technologies, Inc., PR Newswire

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