Never a company to be backward in coming forward with its news, embolic protection specialist, InspireMD, Inc. tells us it has received CE mark approval for its new CGuard RX rapid exchange system for its MicroNet™ covered carotid stent technology.
Background
The proprietary CGuard EPS (embolic protection system) uses the same MicroNet technology as that featured on the MGuard™ and MGuard Prime™ coronary devices. The technology seeks to protect patients from plaque debris and blood clots breaking off and which can lead to life threatening strokes.
The new state- of-the-art RX delivery system will enable clinicians to place the CGuard technology using an easy-to-use, and familiar, delivery system. The CGuard MicroNet mesh covered carotid stent remains unchanged.
At the same time as announcing its regulatory win, InspireMD points us at positive 6 month follow up data from its CGuard™ CARENET (CARotid Embolic protection Study using microNET) trial: Prof. Piotr Musiałek, Co- Principal Investigator for the CARENET study, from Jagiellonian University Medical College at John Paul II Hospital, Krakow, Poland, presented the CARENET 6 month data at a late breaking trial session at the LINC (Leipzig InterveNtional Course) Meeting.
Results evidenced:
- One MACCE (major adverse cardiac and cerebrovascular) event reported at 6 months which was not device related. 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.
- The external carotid artery showed unimpeded flow in 100% 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 this 6 month data showing minimal restenosis concern, and 100% patent internal and external carotid arteries, indicates that the therapeutic benefits of the CGuard™ MicroNet technology may extend well beyond the acute procedural period.
Company comments
Alan Milinazzo, CEO of InspireMD, commented, “We are very pleased to have received the CE mark approval for our CGuard RX rapid exchange system. This is an important milestone for the Company as it creates significant near term commercial opportunities for us.”
Referring to the clinical findings he said, “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.”
Source: PR Newswire
published: January 27, 2015 in: Approval/Clearance, Clinical Studies/Trials, Congresses and Meetings, Vascular