The British Standards Institution (BSI) has given its approval to begin full-scale manufacturing of Micell Technologies’s MiStent SES Sirolimus Eluting Absorbable Polymer Coronary Stent System.
The approval is for commercial distribution of Micell’s system in the European Union and other countries where the CE Mark is accepted.
Micell’s manufacturing partner, Surgical Technologies (STI), will be the primary contract manufacturer of MiStent SES.
MiStent SES is a new drug-eluting stent with a bioabsorbable coating designed to promote optimal healing in patients with coronary disease.
Micell chairman and chief executive officer Arthur J. Benvenuto said: "With STI’s expertise and performance in full-service medical device contracting and Micell’s highly efficient manufacturing process, we are accommodating the controlled commercial launch of MiStent SES in CE Mark countries as well as supplying clinical trials currently being conducted in Europe and China.
"We also are prepared to support a commercial launch in China once granted regulatory approval."
Commercially available through Micell’s distribution partner, STENTYS, MiStent SES has already received a CE Mark in the European Union and has been made available in Western Europe from earlier this year.
In the second half of 2015, the system will be launched in selected countries within the Middle East, South-East Asia and Latin America.
Hefei Life Science Technology Park Investment and Development will serve as the exclusive distributer for Micell’s sytem in China, Hong Kong and Macau.
In the US, MiStent SES is not approved for sale or use by the Food and Drug Administration (FDA).