Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. FDA PMA
- Generic Name
- Intracranial coil-assist stent FDA PMA
Identifiers
- PMA Number
- P170013 FDA PMA
- FDA Product Code
- QCA FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Neurology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. is an Intracranial Coil-Assist Stent, designed to assist in neurovascular embolization procedures. It is intended for deployment within wide-neck intracranial aneurysms (≥4 mm neck width or dome-to-neck ratio <2) in patients aged 18 years or older, with parent vessel diameters ranging from 2.0 mm to 4.5 mm.
This device is supplied as a single-use, non-sterile kit and requires sterilization prior to use. It is classified as a Class III medical device under FDA regulations and has received PMA approval (P170013). Deployment is performed via microcatheter under fluoroscopic visualization, adhering to neurointerventional procedures in a sterile operating environment.
Frequently asked questions
What is the primary purpose of the LVIS and LVIS Jr. devices in neurovascular procedures?
The LVIS and LVIS Jr. are designed as intracranial coil-assist stents to assist in embolization procedures for wide-neck intracranial aneurysms. They are specifically intended for deployment within aneurysms that have a neck width of 4 mm or greater, or a dome-to-neck ratio of less than 2, in patients aged 18 or older. This helps stabilize coils during treatment, improving occlusion outcomes in challenging aneurysm geometries.
How are the LVIS and LVIS Jr. devices supplied, and what preparation is required before use?
The LVIS and LVIS Jr. are supplied as single-use, non-sterile kits. Since they are not sterile out-of-the-box, they must be sterilized prior to use in a sterile operating environment, following standard neurointerventional procedure protocols. This ensures compliance with sterile field requirements during deployment.
What parent vessel diameters are compatible with the LVIS and LVIS Jr. devices?
The devices are intended for use in parent vessels with diameters ranging from 2.0 mm to 4.5 mm. This specification ensures proper sizing and deployment within the targeted aneurysm environment, aligning with the device’s intended use for wide-neck intracranial aneurysms.
Are the LVIS and LVIS Jr. devices reusable, or are they meant for single-use only?
The LVIS and LVIS Jr. are explicitly designed for single-use only. This is reinforced by their non-sterile supply and the requirement for sterilization prior to each procedure, which aligns with standard practices for single-use medical devices in neurointerventional settings.
What regulatory pathway was followed for the approval of the LVIS and LVIS Jr. devices?
The LVIS and LVIS Jr. devices received FDA approval through the Premarket Approval (PMA) pathway, with the PMA number listed as P170013. This pathway is typically used for high-risk medical devices like Class III stents, ensuring rigorous evaluation of safety and effectiveness before market authorization.
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 | P170013 | Class III | Active |
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Manufacturer
- Manufacturer
- Microvention Inc.
- FDA Applicant
- MicroVention, Inc.
Sources (1)
- FDA PMA P170013 24 fields · synced Sep 18, 2026