InspireMD, Inc. NSPR ("Inspire" or the "Company"), the developer
of the MGuard™ Embolic Protection Stent (EPS), announced today that on April
19, 2013, the Company received an approval with conditions for its
Investigational Device Exemption (IDE) application with the U.S. Food and Drug
Administration (FDA). An approval with conditions indicates that the FDA
concurs with the overall trial design and while minor details are being
finalized, allows the company to initiate enrollment in the MASTER II IDE
trial.
The multi-center, randomized trial will consist of 1,114 patients suffering
from ST Elevation Myocardial Infarction (STEMI), throughout 35 sites in the
U.S. and an additional 35 sites in Europe, and will support the Company's
application to market its MGuard™ Prime MicroNet™ covered coronary stent
system in the US.
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