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Micell Technologies Receives CE Mark Approval for MiStent SES
Date:6/12/2013

ages of MiStent SES's unique features, with serial angiographic, intravascular ultrasound (IVUS) and OCT assessment of patients at early (6/8 month) and late (18 month) time points.  Data analysis of the groups using matched pairs shows no progression of LLL (0.10 / 0.09 mm and 0.09 mm respectively). 

Patrick W. Serruys, MD, PhD, Professor of Interventional Cardiology at the Erasmus University, Rotterdam, The Netherlands, said, "MiStent SES uniquely offers physicians an effective DES that converts to a bare metal stent (BMS) in 45-60 days while still providing drug for suppression of neointimal hyperplasia up to 9 months. The MiStent SES brings us a step closer to the ideal DES, which may provide long-term efficacy while still allowing normal vessel healing." 

The company is preparing for a post-marketing clinical program of 2,000 patients comparing the MiStent SES to the Xience® Everolimus Eluting Coronary Stent System in a randomized design to show non-inferiority of target lesion failure at 12 months and superior performance by the MiStent SES at 24 months with significantly less progression of LLL.

With this CE Mark approval, Micell is preparing to make the MiStent SES commercially available in Europe and other markets where CE Mark approval can expedite the registration process. The MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System is not currently available for sale in any market.

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
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SOURCE Micell Technologies, Inc.
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