InspireMD, Inc. announced on July 9, 2025, the official commercial launch of its CGuard Prime carotid stent system in the U.S. This follows the recent Premarket Application (PMA) approval from the U.S. Food and Drug Administration (FDA).
CEO Marvin Slosman stated that this U.S. commercial launch marks a pivotal milestone in InspireMD's expansion history, building on its double-digit market share across more than 30 countries. The company has spent the past year preparing, assembling a commercial team of industry veterans and establishing a robust operational infrastructure.
The CGuard Prime system is engineered to minimize embolism risk with its dual-layer design, combining a large open-cell frame with the smallest mesh pore size. Its MicroNet bio-stable mesh traps and seals thrombus and plaque, while SmartFit technology ensures precise vessel wall apposition without needing tapered versions.
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