InspireMD Submits FDA Premarket Approval Application for CGuard Prime Carotid Stent System
Key Insights
InspireMD has submitted a Premarket Approval (PMA) application to the FDA for its CGuard Prime carotid stent system (search), aimed at preventing stroke (search).
The PMA is supported by positive data from the C-GUARDIANS clinical trial, which demonstrated a low major adverse event rate of 1.95% at one year.
The C-GUARDIANS trial enrolled 316 patients across U.S. and European sites, evaluating the safety and efficacy of CGuard for carotid artery stenosis (search).
InspireMD, Inc. has announced the submission of a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its CGuard Prime carotid stent system (search). This submission marks a significant step toward potential U.S. market availability of the device, which is designed to prevent stroke (search) by treating carotid artery stenosis (search). The application is based on data from the C-GUARDIANS pivotal clinical trial, presented at LINC 2024, which demonstrated favorable outcomes.
C-GUARDIANS Trial Results
The C-GUARDIANS clinical trial, a prospective, multi-center study, enrolled 316 patients across 24 sites in the U.S. and Europe. The trial evaluated the safety and efficacy of the CGuard Prime stent in patients with carotid artery stenosis (search). Key findings from the trial include a primary endpoint major adverse event rate of 1.95% through twelve months post-procedure. The primary endpoint was a composite of death, stroke (search) or myocardial infarction (DSMI) through 30 days or ipsilateral stroke 31 - 365 days post-index procedure. According to InspireMD, this is the lowest reported event rate for any carotid stent or embolic protection device pivotal trial to date.
Management Commentary
Marvin Slosman, chief executive officer of InspireMD, 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 (search) 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. 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.”
About CGuard Prime
The CGuard Prime Embolic Prevention Stent System (EPS) utilizes InspireMD’s MicroNet technology. InspireMD aims to establish its products as the standard for carotid stenting, providing acute results and durable, stroke (search)-free long-term outcomes.
Anticipated Launch
Subject to FDA approval, InspireMD anticipates a U.S. commercial launch of the CGuard Prime carotid stent system (search) in the first half of 2025.