Transforming medical devices for improved patient outcomes

MiStent SES®

Micell’s flagship product is the MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES). Taking full advantage of 25 years of stent design learnings, MiStent SES is designed to limit the duration of polymer exposure, optimize healing, more precisely and consistently control drug elution, and ultimately improves safety and clinical outcomes.

MiStent SES has a CE mark and is available for sale in many countries around the world. MiStent SES is not approved for sale/use within the United States, at this time. (For more information on international distribution partners, please contact us.)

Micell_thumbWatch the TCTMD panel discussion of MiStent SES, with expert commentary from Martin Leon, M.D., Elazer Edelman, M.D., Ph.D., Alexandra Lansky, M.D., and Robbert de Winter, M.Sc., M.D., Ph.D.

Ultra-Thin Design Promotes Healing
MiStent SES leverages the strengths of a cobalt chromium coronary stent system, a state-of-the-art, ultra-thin strut platform that provides excellent deliverability, conformability and flexibility. The MiStent is 64 microns in thickness yet does not compromise performance when it comes to longitudinal compression or elongation. The thinness of the stent struts helps to minimize vessel damage to the surrounding tissue, limits flow disruption decreasing the risk of early stent thrombosis, and allows for more rapid re-endothelialization, while still providing needed support to the artery.

MiStent SES is unique based on its bioabsorbable polymer coating and its use of a crystalline form of sirolimus. The polymer is designed to flow away from the stent struts, which minimizes tissue reactivity and thus allows for accelerated tissue healing. The polymer is eliminated from the stent structure in 45 to 60 days, and is absorbed from the surrounding tissue within three months.

The application of crystalline sirolimus to the stent through a proprietary supercritical fluid technology allows for a near linear release of the drug rather than an uncontrolled burst and immediate taper, as is often found with other drug-eluting stents. This sustained release provides therapeutic drug levels well beyond the time it takes for the polymer to be absorbed, thereby significantly reducing potential inflammatory response to the polymer itself. Additionally, the sustained controlled drug release provides an anti-restenotic effect in the treated area beyond most traditional DES products.

Improved Clinical Outcomes
Based on clinical evidence, the unique design of MiStent SES has shown improved clinical outcomes, including:

  • Minimal progression of late lumen loss or neoatheroma formation
  • Low Target Lesion Revascularization (TLR) over long-term follow-up
  • Short duration of polymer presence and even distribution of drug to minimize risk of early and late stent thrombosis

Drug Delivery vs. Polymer Dissolution
MiStent SES is the only bioabsorbable polymer coated drug-eluting stent with active drug present after the polymer is fully absorbed.

No Late Catch-up of In-Stent Late Lumen Loss (LLL) observed with MiStent vs. other DES
Progression of LLL is seen by many as a surrogate marker for TLR. The lower the progression, the lower the rate of restenosis over time. The unique clinical findings of no LLL progression or neoatheroma formation are likely contributors to MiStent’s low TLR progression rate.

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Gada H. et al. 5-year results of a randomized comparison of XIENCE V everolimus-eluting and TAXUS paclitaxel-eluting stents: final results from the SPIRIT III trial JACC:CI (6,12) 2013;1263-1266 Onuma Y. et al. Five-year long-term clinical follow-up of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery disease: the SPIRIT II trial, EuroIntervention 2013,8:1047-1051
Ormiston J. Three-year results of the DESSOLVE I first-in-human trial and the DESSOLVE II randomized trial of a sirolimus-eluting stent with fully absorbable polymer. J AM Coll Cardiol 2014, 64(16_S):doi.10.1016/j.jacc.2014.06.636