Micell Technologies Announces Completion of Enrollment in MiStent Randomized Trial Against Xience

DURHAM, N.C., Micell Technologies, Inc. announced the completion of patient enrollment in DESSOLVE III, a 1,400 patient, 20 center, randomized clinical trial comparing MiStent^® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES^®) to XIENCE Everolimus Eluting Coronary Stent System^® (Xience^®).  

DESSOLVE III is a prospective, balanced, randomized, controlled, single-blind, multi-center study comparing clinical outcomes between MiStent SES and Xience in a "real world, all-comers" patient population.  Patients in the trial suffered from symptomatic coronary artery disease, including those with chronic stable angina, silent ischemia, or acute coronary syndrome, and qualified for percutaneous coronary interventions.  The primary endpoint for this trial is a non-inferiority comparison of a device-oriented composite endpoint (DOCE) or target lesion failure (TLF) of the MiStent SES group versus the Xience group at 12 months' post-procedure. 

Arthur J. Benvenuto, chairman and chief executive officer of Micell said, "This is another significant milestone in building the clinical data for MiStent. Currently, we have DESSOLVE C enrolling in China with plans to expand our clinical programs to the United States and Japan."

MiStent is highly differentiated within the new class of bioabsorbable drug-eluting stents in that its design includes a crystalline drug that remains in the tissue for an extended period – well beyond the rapidly absorbing polymer. The long-term performance of this innovative drug delivery profile has been presented in recent publication in EuroIntervention, as submitted by William Wijns, M.D., the Co-Director of Cardiovascular Center, Aalst, Belgium.   

MiStent SES has CE Mark in the European Union, and is being distributed exclusively by STENTYS around the world with the exception of the United States, Canada, China, South Korea and Japan. STENTYS is currently conducting a controlled launch in select countries in Europe, the Middle East, Asia and Latin America. 

"We are pleased by the speed with which the study was enrolled in the head-to-head comparison against market-leading Xience," said Gonzague Issenmann, chief executive officer of STENTYS. "Through this study and our ongoing controlled launch of MiStent, we are receiving outstanding feedback on the product's performance as a workhorse stent."

About the MiStent SES

MiStent SES^® is designed to optimize healing in patients with coronary artery disease.  The rapidly absorbable coating of the MiStent SES, which contains crystalline drug (sirolimus) and an absorbable polymer, is intended to precisely and consistently provide for 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.

Using an approved drug (sirolimus) and polymer (PLGA), Micell's patented supercritical fluid technology allows a rigorously controlled drug/polymer coating to be applied to a bare-metal stent.  The MiStent SES leverages the benefits of a cobalt chromium coronary stent system, a state-of-the-art, thin-strut, bare-metal stent, which has demonstrated excellent deliverability, conformability and flexibility.

EU approval of MiStent SES was supported by clinical data from two studies, DESSOLVE I and II, which demonstrated superior in-stent late lumen loss rates and an excellent safety profile.  The 4- year data was recently presented by Alexandra Lansky, M.D., Director, Yale Cardiovascular Clinical Research Program, Yale University School of Medicine, New Haven, Conn., at the 27^th Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference held in San Francisco.   Highlights of the data included no target lesion events in the DESSOLVE I study and sustained clinical outcomes in both DESSOLVE I and II through four years' follow-up. There have been no probable or definite stent thromboses in either study. Importantly, MiStent SES continues to show a low combined target lesion revascularization (TLR) rate for DESSOLVE I and II of 2.7% at 4 years' follow-up, which is consistent with previously demonstrated lack of late loss progression in the DESSOLVE I study.