July 9, 2025 — InspireMD, Inc., developer of the CGuard Prime carotid stent system for the prevention of stroke, announced the official commercial launch of the CGuard Prime carotid stent system in the U.S., following its premarket application (PMA) approval from the U.S. Food and Drug Administration (FDA).
The CGuard Prime was engineered specifically to minimize both early and late embolism risk by effectively trapping potential emboli against the arterial wall while preserving external carotid artery perfusion. This innovative device features three key advantages: First, a dual layer design that combines the largest open-cell frame with the smallest mesh pore size available. Second, the MicroNet, a bio-stable mesh crafted from a single 20 μm Polyethylene Terephthalate (PET) strand that traps and seals thrombus and plaque against the vessel wall to prevent embolization. Third, SmartFit technology eliminates the need for tapered versions while ensuring precise vessel wall apposition.
“Our U.S. commercial launch marks a pivotal milestone in InspireMD’s expansion history, having already secured double-digit market share across more than 30 countries,” said Marvin Slosman, Chief Executive Officer of InspireMD. “We’ve spent the past year meticulously preparing for this moment, assembling a world-class commercial team comprised of industry veterans with deep expertise and longstanding relationships. Backed by this all-star team and a robust operational infrastructure, we are poised to execute a highly impactful U.S. launch. We’re incredibly grateful to everyone who contributed to making this possible and couldn’t be more excited about the road ahead.”
“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,” said Dr. D. Chris Metzger, System Vascular Chief at OhioHealth. “CGuard’s unique design makes a real difference in addressing the complexities of carotid artery disease, offering enhanced embolic protection without compromising deliverability. 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 U.S.”
“Our team at Ballad Health is thrilled to have contributed to the journey of this novel next generation carotid device. From initiating the first C-GUARDIANS enrollments in 2021 and leading enrollment throughout the trial to supporting the first commercial case by Dr. Chris Metzger, we have been a crucial contributor to the full life cycle of this technology to date. Our efforts reflect the commitment of the Ballad Health System to advancing innovation to improve patient care and offering the latest in medical breakthrough technologies,” shared Alan Levine, Chairman and CEO, Ballad Health.
For more information, please visit www.inspiremd.com.
July 08, 2025 
