InspireMD (Nasdaq:NSPR) announced today that it submitted a premarket approval (PMA) application to the FDA for its CGuard system.

The company designed the CGuard Prime carotid stent system, made from nitinol, 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.”