InspireMD Gets CE Mark for Addition to its Line of Carotid Stent Technology

Boston, Mass.-based InspireMD Inc., a developer of embolic protection systems (EPS), received CE mark for the CGuard RX rapid exchange system for its MicroNet covered carotid stent technology. 
 
The company also released positive 6-month follow up data from its CGuard CARENET (CARotid Embolic protection Study using microNET) trial at the Leipzig Interventional Course (LINC) meeting in Leipzig, Germany.
 
The RX delivery system will enable clinicians to place the CGuard technology via an easy-to-use, and familiar, delivery system, according to the company. The CGuard MicroNet mesh-covered carotid stent remains unchanged.
 
The proprietary CGuard EPS uses the same MicroNet technology featured on the company’s MGuard and MGuard Prime coronary embolic protection systems. The MicroNet technology is a single fiber knitted mesh wrapped on an open cell stent platform designed to trap debris that can dislodge and travel downstream after a patient is treated with traditional stenting methods. This technology is designed to protect patients from plaque debris and blood clots breaking off and which can lead to life threatening strokes. 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.
 
For the data provided during the LINC meeting, there was only one major adverse cardiac and cerebrovascular event (MACCE) reported at 6 months that was not device related. According to the firm, this 6-month MACCE rate is substantially lower than MACCE rates reported in other conventional carotid stenting trials.
 
“The duplex ultrasound analysis performed at 6 months confirmed widely patent carotid arteries, which were stented with the CGuard as determined by flow measurements indicating no sign of vessel narrowing, consistent with historical data of conventional carotid artery stenting,” company officials reported in a recent release.
 
Importantly, the external carotid artery showed unimpeded flow in 100 percent of cases demonstrating that the MicroNet allows excellent blood flow into bifurcated arteries. The reduction in both the incidence and the volume of new ischemic lesions, as well as the new 6-month data showing minimal restenosis concern, and 100 percent patent internal and external carotid arteries, indicate, officials noted, that the therapeutic benefits of the CGuard MicroNet technology may extend beyond the acute procedural period
 
“We are very pleased to have received the CE mark approval for our CGuard RX rapid exchange system,” said Alan Milinazzo, CEO of InspireMD. “This is an important milestone for the Company as it creates significant near term commercial opportunities for us. Physicians continue to be impressed with the superior clinical data and our 6-month results further validate that CGuard with MicroNet may represent a superior next generation of stenting technology. We plan to use the new clinical data and the RX approval to expand our commercial launch activities starting immediately.”
 
CGuard EPS has CE mark, though it is not yet approved by the U.S. Food and Drug Administration.