InspireMD (Nasdaq:NSPR) announced today that it launched its CGuard Prime carotid stent in the U.S. after receiving FDA premarket approval (PMA) last month.
The CGuard embolic prevention stent (EPS) system — designed to prevent stroke — received CE mark last month as well. It utilizes the company’s MicroNet technology for strong acute results and durable, stroke-free, long-term outcomes.
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Miami-based InspireMD developed the next-generation carotid stent system based on physician feedback. It features improved deliverability and deployment. It builds on the original CGuard design, which uses the company’s proprietary MicroNet mesh. The mesh helps reduce the risk of stroke by trapping embolic debris and preventing plaque prolapse.
The novel, mesh-covered stent combines a large open-cell frame with small mesh pore size. This prevents plaque protrusion through the stent for lasting embolic protection demonstrated beyond five years. It also features SmartFit technology to eliminate 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, CEO 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.”
