InspireMD has officially commenced the commercial launch of its CGuard Prime carotid stent system in the United States, following premarket approval (PMA) from the U.S. Food and Drug Administration (FDA).
The CGuard Prime is engineered to minimize the risk of embolic events occurring both immediately and over time. It achieves this by securely capturing embolic debris against the artery wall, all while ensuring continuous blood flow through the external carotid artery.
This system utilizes a unique dual-layer design, pairing a wide open-cell frame with an exceptionally fine mesh, currently the smallest pore size available on the market.
It also includes MicroNet™ mesh technology, made from a single 20-micron strand of polyethylene terephthalate (PET), which helps to contain thrombus and plaque to minimize embolization.
Its SmartFit™ technology ensures accurate wall apposition without the need for tapered devices.
The U.S. launch builds on InspireMD’s established presence in over 30 countries, where the CGuard Prime has already captured a substantial share of the carotid stent market.
The system has undergone both clinical trials and real-world use at several leading U.S. healthcare institutions. Medical professionals involved in these evaluations have emphasized the device's ability to enhance stroke prevention and improve procedural efficiency during carotid interventions.
Ballad Health, a key participant in the C-GUARDIANS clinical trial, played an instrumental role in the system’s development. The organization contributed to early trial enrollment and facilitated the first commercial use of the device in the United States.
This launch marks a major advancement for InspireMD as it continues to expand access to innovative carotid treatment solutions aimed at lowering the risk of stroke.
