The company designed the CGuard Prime carotid stent system for the treatment of carotid artery stenosis. It based its PMA application on positive one-year data from the company’s C-GUARDIANS pivotal clinical trial. The trial evaluated the safety and efficacy of CGuard in 316 patients across 24 sites in the U.S. and Europe.
C-GUARDIANS demonstrated a primary endpoint major adverse event rate of 1.95% through 12 months post-procedure. InspireMD says that marked the lowest such event rate reported for any carotid stent or embolic protection device pivotal trial to date.
InspireMD’s CGuard embolic prevention stent (EPS) system — designed to prevent stroke — received CE mark earlier this year. It utilizes the company’s MicroNet technology for strong acute results and durable, stroke-free, long-term outcomes. In July, the company also brought in $17.9 million from warrants exercised following the release of the positive C-GUARDIAN results.
“The submission of our PMA application to the FDA represents a significant step forward in our quest for U.S. approval of our next generation CGuard Prime stent to address carotid artery disease and stroke prevention with its best-in-class clinical outcomes,” said Marvin Slosman, InspireMD CEO. “We look forward to the agency’s review of our application, which we have provided in a modular submission to facilitate the most efficient review process.
“Concurrently, we continue to build what I consider to be world class U.S. commercial and operational infrastructure to enter the U.S. market with as much momentum as possible to offer to this breakthrough technology.”
