InspireMD Inc. (NASDAQ:NSPR) saw its shares rise 4% in premarket trading after the company officially launched its CGuard Prime carotid stent system in the U.S. market.
The commercial debut follows the product’s premarket approval by the U.S. Food and Drug Administration. CGuard Prime is engineered to reduce the risk of embolism both shortly after and long after implantation by securing embolic material against artery walls, while allowing uninterrupted blood flow through the external carotid artery.
The CGuard Prime system incorporates a dual-layer structure featuring an open-cell frame and what InspireMD says is the “smallest mesh pore size available.” The stent utilizes the company’s proprietary MicroNet™ mesh—constructed from a single 20 μm strand of Polyethylene Terephthalate—and SmartFit™ technology, which removes the need for tapered stents.
“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.
Dr. D. Chris Metzger, System Vascular Chief at OhioHealth, praised the stent’s performance: “CGuard’s design makes a real difference in addressing the complexities of carotid artery disease, offering enhanced embolic protection without compromising deliverability.”
In anticipation of the U.S. launch, InspireMD has spent the past year assembling a seasoned commercial team to spearhead its market entry strategy.
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