Promising Six Month Results from InspireMD’s CGuard™ CARENET Trial

InspireMD, Inc., best known to our pages for its embolic protection systems (EPS), will be presenting six month follow-up data from its CGuard™ CARENET trial at the forthcoming Leipzig InterveNtional Course (LINC) later this month.


Those familiar with InspireMD’s offerings will know that these are stents with a difference. The difference lies in the mesh covering that is designed to prevent chunks of embolic debris from dropping off the wall of the stented vessel and into the bloodstream. InspireMD’s proprietary CGuard EPS uses the same MicroNet technology featured on the MGuard™ and MGuard Prime™ coronary embolic protection systems. The size, or aperture, of the MicroNet ‘pore’ is only 150-180 microns in order to maximize protection against the potentially dangerous plaque and thrombus within the carotid artery.

The CARENET trial (CARotid Embolic protection Study using microNET) 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.

In a new press release InspireMD says 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 CGuardTM CARENET data will be presented during the main carotid session at LINC titled, “Deep Dive Session: Carotid Revascularization” chaired by Dr. Frank Veith and Dr. William Gray on Tuesday, January 27 from 9:00am – 12:30pm. Prof Piotr Musiałek, Co- Principal Investigator for the CARENET study, from Jagiellonian University Medical College at John Paul II Hospital, in Krakow, Poland will present this CARENET late breaking clinical data in his talk titled, “The CARENET All-Comer Trial Using the CGuardTM MicroNetTM Covered Embolic Prevention Stent.”

In addition to presenting all-comer data from the CARENET trial he will also present the 6 month follow up data from the study that was originally presented at TCT 2014.

CGuard EPS is CE Marked, but not approved for sale in the U.S. by the U.S. FDA at this time.

Company comments

Alan Milinazzo, CEO of InspireMD, commented, “We continue to be impressed with the clinical data from our CGuard CARENET study. After we first presented our 30-day follow-up data at TCT 2014 in September of last year, we gained additional market feedback through a limited market release of the technology. Now, the six-month follow-up data, to be presented at LINC in a few weeks, will show that the CGuard has minimal restenosis concern when compared to other carotid stents. In addition, Mr. Milinazzo added, “this data, combined with the earlier DW-MRI data showing a vast reduction in the incidence, and volume, of new ipsilateral lesions continues to validate the short and long term benefits of this MicroNet covered technology when treating patients with carotid artery disease.”

Source: PR Newswire


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