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www.fdanews.com/articles/172760-bsi-approves-micells-mistent-ses-for-full-scale-manufacturing

BSI Approves Micell’s MiStent SES for Full-Scale Manufacturing

August 24, 2015

The British Standards Institution has approved Micell Technologies’ application to begin full-scale manufacturing of the MiStent SES sirolimus-eluting absorbable polymer coronary stent system for distribution in the EU and other countries where the CE mark is accepted.

The device is designed to promote optimal healing in patients with coronary disease with its bioabsorbable coating. Surgical Technologies will be the primary contract manufacturer of the system.

The Durham, N.C., devicemaker launched MiStent SES in Western Europe earlier this year though its distribution partner STENTYS. Availability will be expanded in the second half of 2015 through selected countries in the Middle East, Southeast Asia and Latin America.

Micell says it is also supplying the stent for clinical trials being conducted in China, and will launch it in China once regulatory approval is obtained. — Michael Cipriano