Micell, a US-based biomedical company, has received CE (Conformité Européenne) Mark clearance for its MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES).
MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES) introduces a thin strut stent that features elimination of the coating from the stent in 45 - 60 days and the complete absorption of the polymer coating within 90 days.
The MiStent SES is claimed to be 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.
Micell CEO Arthur Benvenuto said that 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," Benvenuto added.
The MiStent SES approval is supported by in-depth clinical analysis from the DESSOLVE I and DESSOLVE II clinical trials.
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 Sirol imus Eluting Absorbable Polymer Coronary Stent System is not currently available for sale in any market.