InspireMD Wins FDA Approval to Begin US Regulatory Trial for IDE App

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.