Micell Technologies Initiates MiStent SES Trial in China
Micell Technologies said Wednesday it has started enrolling patients in its clinical trial evaluating the MiStent SES sirolimus-eluting stent system for coronary artery disease.
The study, which is comparing the device against Essen Technologies’ Tivoli stent system, has a primary endpoint of nine-month in-stent late lumen loss. The Durham, N.C., company expects to enroll about 428 patients across 18 clinical sites in China.
Additionally, clinicians will follow up with patients at three years to examine their late lumen loss progression.
Chairman and CEO Arthur J. Benvenuto says the morbidity and mortality rates of cardiovascular disease in China are on the rise, posing a significant health risk.
The MiStent SES is available in Europe in select markets. A wider launch in the EU, Middle East, Southeast Asia and Latin America is set for the second half of this year. — Jason Scott