Micell Technologies Receives CE Mark Approval for MiStent SES

June 12, 2013—Micell Technologies, Inc. (Durham, NC) received CE Mark approval for its MiStent sirolimus-eluting absorbable polymer coronary stent system (SES) and is preparing to make the MiStent SES commercially available in Europe and other markets where CE Mark approval can expedite the registration process. MiStent SES is a thin-strut stent that features elimination of the coating from the stent in 45 to 60 days and the complete absorption of the polymer coating within 90 days and provides local drug delivery both during and after the period of polymer absorption, thereby eliminating long-term polymer exposure, the company stated.

According to the company's press release, the MiStent SES approval is supported by the DESSOLVE I and DESSOLVE II clinical trials. The DESSOLVE I first-in-human study provided serial angiographic, intravascular ultrasound, and optical coherence tomography assessment of patients at early (6/8 months) and late (18 months) time points. Data analysis of the groups using matched pairs showed no progression of LLL (late lumen loss; .10 mm/.09 mm and .09 mm, respectively).

DESSOLVE II was a randomized, multicenter study of 184 patients with documented stable or unstable angina pectoris. The study met its primary endpoint: superiority of MiStent SES in minimizing in-stent late lumen loss at 9 months as compared to the Endeavor Sprint drug-eluting stent (DES; Medtronic, Inc., Minneapolis, MN; P < .001). At 9-month follow-up, in-stent LLL was .27 mm with a target lesion revascularization rate of .9%. The major adverse cardiac event rates were 4.3% for MiStent SES and 6.7% for Endeavor. In a subgroup of patients, optical coherence tomography and endothelial function testing confirmed good vessel healing with excellent strut coverage and normal endothelial function.

Patrick W. Serruys, MD, PhD, who is Professor of Interventional Cardiology at the Erasmus University in Rotterdam, The Netherlands, commented, "MiStent SES uniquely offers physicians an effective DES that converts to a bare-metal stent in 45 to 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 postmarketing clinical program of 2,000 patients comparing the MiStent SES to the Xience (Abbott, Santa Clara, CA) everolimus-eluting coronary stent system. The MiStent SES is not currently available for sale in any market, the company advised.