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CGuard Prime Carotid Stent System

by InspireMD, Ltd. FDA registration: Israel PMA

PMA P240029 Product code NIM

Overview

The CGuard Prime Carotid Stent System is a carotid stent indicated for improving carotid luminal diameter. It is intended for use in patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.

This device is indicated for patients with neurological symptoms and 50 percent or greater stenosis, or patients without neurological symptoms and 80 percent or greater stenosis, in vessels with reference diameters between 6.4mm and 9.0mm. It must be used in conjunction with embolic protection devices specified in the labeling and has received FDA PMA authorization.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

Recall ongoing. 6 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP240029 Date23 Jun 2025ApprovedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Active

Recalls

6 recalls · 6 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-2326-2026 FDA Class II initiated 1 May 2026
    • Ongoing Z-2325-2026 FDA Class II initiated 1 May 2026
    • Ongoing Z-2327-2026 FDA Class II initiated 1 May 2026
    • Ongoing Z-2330-2026 FDA Class II initiated 1 May 2026
    • Ongoing Z-2328-2026 FDA Class II initiated 1 May 2026
    • Ongoing Z-2329-2026 FDA Class II initiated 1 May 2026

    Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

Specification

PMA · synced 25 Oct 2026

Generic Name
Stent, carotid
PMA Number
FDA Product Code
NIM
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

Other devices from InspireMD, Ltd.

Questions

  • What specific patient criteria must be met for the CGuard Prime Carotid Stent System to be used according to its FDA authorization?

    The CGuard Prime Carotid Stent System is authorized for patients at high surgical risk for carotid endarterectomy who require revascularization. It is indicated for patients with neurological symptoms and **≥50% stenosis** of the carotid artery, or those without symptoms but with **≥80% stenosis**, as measured by angiogram. Additionally, the target vessel must have a reference diameter between **6.4mm and 9.0mm** at the lesion site. Use requires pairing with embolic protection devices specified in the labeling.

  • Is the CGuard Prime Carotid Stent System intended for single-use or reusable applications?

    The CGuard Prime Carotid Stent System is designed for **single-use only**. Medical devices of this class—particularly those involving vascular interventions—are not engineered for reprocessing to ensure patient safety and sterility. Always follow the manufacturer’s instructions for one-time deployment.

  • What vessel diameter range does the CGuard Prime Carotid Stent System support, and how does this affect selection?

    The system is sized for vessels with **reference diameters between 6.4mm and 9.0mm** at the target lesion. This range ensures compatibility with common carotid or internal carotid arteries in patients requiring revascularization. Clinicians should verify vessel diameter via angiogram before selection to confirm the appropriate stent size for optimal luminal diameter improvement.

  • How is the CGuard Prime Carotid Stent System supplied, and are there any special handling requirements?

    While the exact packaging details are not provided, carotid stent systems like this are typically supplied **sterile and pre-packaged** for single-use procedures. Handling should follow sterile technique protocols to prevent contamination. The system must be used in conjunction with **embolic protection devices** as specified in the labeling, requiring coordination between the stent and complementary components during deployment.

  • What regulatory pathway was followed for FDA authorization of the CGuard Prime Carotid Stent System?

    The CGuard Prime Carotid Stent System received **FDA Premarket Approval (PMA)** under PMA number **P240029**, indicating a rigorous review process for high-risk devices. This classification (Class III) reflects its role in treating carotid artery stenosis, where safety and efficacy are critically evaluated before market authorization. The authorization is tied to the specific indications and embolic protection requirements outlined in the labeling.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA PMA P240029 23 fields · synced 25 Oct 2026