Eurocor GmbH, a group company of Opto Circuits (India), has announced that their partner Micell Technologies, Inc. received Conformite Europeenne (CE) mark approval for its MiStent Sirolimus Eluting Absorbable Ploymer Coronary Stent System (MiStent SES). The MiStent SES is unique in providing local drug delivery both during and after the period of polymer absorption, thereby eliminating long-term polymer exposure, a potential cause of delayed healing and late adverse events.

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 system is not currently available for sale in any market.

Micell's CEO, Arthur J Benvenuto, said, “The MiStent SES brings a new paradigm of safety without compromise to efficacy or deliverability. With polymer absorption faster than any other DES currently available, we believe the MiStent SES provides a long-term safety profile of a highly deliverable bare metal stent.”

The MiStent SES approval is supported by in-depth clinical analysis from the DESSOLVE I and DESSOLVE II clinical trials. The company is preparing for a post-marketing clinical programme 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.