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News Breaks
April 30, 2014
07:38 EDTNSPRInspireMD announces voluntary field action for MGuard Prime EPS
InspireMD announced that it has initiated a Voluntary Field Action following recent reports of MGuard Prime EPS stent dislodgements. These reports have primarily occurred during the preparation of the MGuard Prime EPS, upon removal of the protective sleeve or during withdrawal of the MGuard Prime EPS into the guide catheter. To date, there have been no reports of any patients being harmed in these recent reports reviewed by the Company.
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October 29, 2014
09:13 EDTNSPRInspireMD's IDE amendment approved by the FDA
InspireMD announced that the FDA has approved the company's submitted IDE amendment for certain manufacturing process changes to the MGuard Prime EPS that were proposed in response to the Company's April 30, 2014 Voluntary Field Action. InspireMD said while patient enrollment in the US MASTER II trial has been discontinued, which was intended to support this IDE application, the FDA's approval of the IDE amendment is an important endorsement of the process changes. The company received European regulatory approval for these process changes in June, and now believes all returned MGuard Prime EPS inventory has been successfully modified and returned to direct hospital customers and the majority of their distributors. As such, the Company resumed full commercial activities in direct markets in Western Europe as of mid-October and expects direct and distributor based selling to ramp up throughout the fourth quarter of 2014.

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