Neuroguard IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection FDA PMA
- Generic Name
- Stent, carotid FDA PMA
Identifiers
- PMA Number
- P240009 FDA PMA
- FDA Product Code
- NIM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Neuroguard IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection is a Class III carotid stent system designed for improving carotid luminal diameter. It combines a self-expanding stent, a post-dilation balloon, and an embolic protection mechanism to reduce embolic risk during carotid revascularization in high-risk patients. The system is intended for use in patients with symptomatic or asymptomatic carotid artery stenosis, as determined by angiography using NASCET methodology, with reference vessel diameters ranging from 4.0 to 8.0 mm.
This system is supplied sterile and intended for single-use, requiring use in conjunction with a primary distal embolic protection device as specified in the instructions for use. It is regulated under an FDA Premarket Approval (PMA) and falls under the product code NIM. The device is designed for use in interventional radiology or neurovascular settings, with no specific MRI safety labeling indicated in the provided data.
Frequently asked questions
What specific types of patients is the Neuroguard IEP® system designed to treat, and how is their carotid stenosis measured?
The Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System is designed for high-risk patients requiring carotid revascularization who meet specific stenosis criteria. It is intended for patients with either symptomatic stenosis (≥50%) or asymptomatic stenosis (≥80%) in the common or internal carotid artery, as determined by angiography using the NASCET methodology. Stenosis is measured as the percentage reduction in the vessel diameter compared to a normal reference segment.
Is the Neuroguard IEP® system reusable, or is it intended for single-use only? How does this affect its sterility?
The Neuroguard IEP® system is explicitly intended for single-use only and is supplied sterile. This design ensures patient safety by preventing cross-contamination between procedures, as reuse could compromise sterility and device integrity. The sterile packaging is designed to maintain this condition until first use.
What reference vessel diameter range does the Neuroguard IEP® system accommodate, and how does this impact its clinical application?
The system is designed for reference vessel diameters between 4.0 mm and 8.0 mm, as specified in the AO statement. This range ensures compatibility with a broad spectrum of carotid artery anatomies while maintaining optimal stent expansion and embolic protection functionality. Clinically, this allows for use in both smaller and larger vessels, broadening its applicability for patients with varying degrees of stenosis.
How is the Neuroguard IEP® system regulated in the U.S., and what does this mean for clinicians or facilities considering its use?
The Neuroguard IEP® system is regulated under an FDA Premarket Approval (PMA) with the product code NIM, indicating it is classified as a Class III device. This means it has undergone rigorous review to demonstrate safety and effectiveness for its intended use—improving carotid luminal diameter in high-risk patients undergoing carotid revascularization. Clinicians should confirm their facility’s compliance with PMA requirements and ensure proper training before use.
Does the Neuroguard IEP® system require additional devices for full functionality, and if so, what are the key considerations?
Yes, the Neuroguard IEP® system must be used in conjunction with a primary distal embolic protection device, as outlined in the instructions for use. This complementary device captures embolic material during stent deployment and post-dilation. Clinicians should verify compatibility with their preferred embolic protection system and follow the IFU to ensure seamless integration and optimal embolic risk reduction.
This description and any FAQs above were generated automatically from registry data 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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P240009 | Class III | Active |
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Manufacturer
- Manufacturer
- Contego Medical, Inc.
Sources (1)
- FDA PMA P240009 23 fields · synced Oct 6, 2026