Stent, Carotid
Basic Information
- Device Name
- Stent, Carotid
- Trade Name
- Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection
- PMA Number
- P240009
- Device Class
- FDA Class 3
- Product Code
- NIM
- Generic Name
- Stent, carotid
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 11, 2024
- Date Received
- March 29, 2024
- Expedited Review
- N
Advisory Committee Statement
This Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection is indicated for improving the carotid luminal diameter in subjects at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below: Patients with symptomatic stenosis of the common or internal carotid artery with >=50% as determined by angiography using NASCET methodology, or Patients with asymptomatic stenosis of the common or internal carotid artery with >=80% as determined by angiography using NASCET methodology; Patients with reference vessel diameters 4.0 8.0 mm. This device is also indicated for post-dilation of the stent component with simultaneous capture and removal of embolic material. The Neuroguard IEP System should always be used in conjunction with an available primary distal embolic protection device as described in the IFU.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NIM | Stent, Carotid | FDA class 3 | Unknown |