InspireMD’s CGuard Prime Carotid Stent System Launched in United States

July 9, 2025—InspireMD, Inc. announced the commercial launch of the CGuard Prime carotid stent system in the United States. On June 24, the company announced FDA premarket approval of the device.

According to the company, the CGuard Prime is designed to minimize both early and late embolism risk by trapping potential emboli against the arterial wall while preserving external carotid artery perfusion.

InspireMD stated that the device’s features include a dual-layer design that combines a large open-cell frame with a small mesh pore size. Additionally, the MicroNet biostable mesh, which is crafted from a single 20-μm polyethylene terephthalate strand, traps and seals thrombus and plaque against the vessel wall to prevent embolization. The company’s SmartFit technology eliminates the need for tapered versions while ensuring precise vessel wall apposition.

D. Chris Metzger, MD, who is System Vascular Chief at OhioHealth in Columbus, Ohio, commented on the device in the InspireMD press release.

“Treating patients with the CGuard Prime system is incredibly meaningful, both personally, for the advancement of innovation at OhioHealth, and for the field of carotid intervention as a whole,” stated Dr. Metzger. “CGuard’s unique design makes a real difference in addressing the complexities of carotid artery disease, offering enhanced embolic protection without compromising deliverability.”

Dr. Metzger continued, “My experience using the system—both in clinical trials and now in practice—reinforces how much demand there is for safer, less invasive alternatives, particularly for patients at higher risk of stroke. This technology represents an important advancement in how we approach stroke prevention in the United States.”