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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.
News For NSPR From The Last 14 Days
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January 13, 2015
09:00 EDTNSPRInspireMD says CGuard data continues to show excellent clinical benefit
InspireMD announced that six month follow-up data from its CGuard CARENET trial continued to show promising clinical benefits, including exceptional safety and efficacy, and most importantly resolution of ischemic lesions and a reduced incidence of restenosis. The reduction in both the incidence and volume of new ischemic lesions, as well as this six-month data showing minimal restenosis concern, indicates that the therapeutic benefits of the CGuard MicroNet technology may extend well beyond the acute procedural period. The CARENET trial recruited a total of 30 patients and showed very promising safety and efficacy with 0% MACCE, meaning no death, stroke or myocardial infarction, at 30 days, substantially lower than in other non-mesh covered carotid stenting trials. Additionally, the incidence of new ischemic ipsilateral lesions as assessed by Diffusion Weighted Magnetic Resonance Imaging after carotid artery stenting was reduced by almost 50% when compared to published historical control groups of non-mesh covered carotid stents. All but one of the new ischemic lesions at 48 hour follow up were completely resolved at 30 days. The CARENET trial also reported an average lesion volume per patient that was 10 times smaller than historical control groups. The ultrasound analysis performed at six months has shown healthy healing of the carotid artery without restenosis concern when compared to other CAS. More detailed data will be presented at the upcoming LINC, or Leipzig InterveNtional Course, meeting in Leipzig, Germany on Tuesday, January 27. InspireMD shares are up 14% in pre-market trading to 98c following the data release.

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