InspireMD (Nasdaq:NSPR) has announced the submission of a premarket approval (PMA) application to the FDA for its CGuard Prime carotid stent system. The device is intended for the treatment of carotid artery stenosis and aims to reduce the risk of stroke. The submission, announced on September 16, 2024, is based on data from the C-GUARDIANS pivotal clinical trial, which demonstrated promising safety and efficacy results.
C-GUARDIANS Trial Results
The C-GUARDIANS trial, a prospective, multi-center study, enrolled 316 patients across 24 sites in the U.S. and Europe. The trial's primary endpoint was the rate of major adverse events (MAE) through 12 months post-procedure. Results showed a MAE rate of 1.95%, which InspireMD claims is the lowest reported for any carotid stent or embolic protection device pivotal trial to date. This low event rate suggests a potentially improved safety profile compared to existing carotid stenting options.
CGuard Technology
The CGuard embolic prevention stent (EPS) system incorporates InspireMD’s MicroNet technology. This design aims to provide strong acute results and durable, stroke-free, long-term outcomes. The CGuard EPS system received CE mark earlier this year, allowing its commercialization in Europe. The device is designed to prevent stroke by capturing and containing embolic debris released during stent placement.
Management Commentary
Marvin Slosman, InspireMD CEO, stated, "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. 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."
Slosman also noted the ongoing efforts to build a U.S. commercial and operational infrastructure in preparation for the potential market entry of the CGuard Prime stent.
