PARADIGM is an investigator-initiated prospective assessment of all-comer percutaneous carotid revascularization in symptomatic and increased-risk asymptomatic carotid artery stenosis through using CGuard mesh-covered embolic prevention stent system.

According to the company, the study indicated that the CGuard system is appropriate for use in an all-comer carotid revascularization population and is associated with favorable angiographic and clinical outcome.

PARADIGM study principle investigator professor Piotr Musialek said: "Our experience with CGuard continues to be very positive. Evidence shows the device’s applicability for use in an all-comer population with no major adverse cardiac or neurological events (MACNE) during the procedure and at 30 days."

According to Musialek, the study from the 71 CGuard procedures in unselected all-comer patients showed the 100% of stent system success and procedure success.

InspireMD CEO Alan Milinazzo said: "We are pleased to see the very positive results from PARADIGM. Together with the other independent clinical studies presented at EuroPCR, it has confirmed confidence in our CGuard Embolic Prevention system."