The Tel Aviv, Israel-based company designed CGuard for the prevention of stroke. It utilizes the company’s MicroNet technology for strong acute results and durable, stroke-free, long-term outcomes.
InspireMD highlighted the importance of the transition to the new European Medical Device Regulations (EU MDR).
“We are very pleased to have now received formal recertification of our CE mark under MDR, allowing us to continue to work to make CGuard EPS the standard of care for carotid artery revascularization in our existing commercial territories while also advancing our new product pipeline using the pathway provided under MDR,” said CEO Marvin Slosman.
The company continues working on an FDA premarket approval (PMA) application for the C-GUARDIANS U.S. IDE trial.
Slosman said the company’s trial “continues to progress nicely.” InspireMD expects primary endpoint results in mid-2024, followed by the final submission to the FDA in the second half of the year. Slosman hopes for potential U.S. approval of the stent in the first half of 2025.
