Intrasaccular Devices
MicroVention Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
Indications for Use
The LVIS and LVIS Jr. are indicated for use with neurovascular embolization coils in patients ≥ 18 years of age for the treatment of wide-neck (neck width ≥ 4 mm or dome to neck ratio < 2) saccular intracranial aneurysms arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4.5 mm.
Key Specifications
- Self-expanding nickel titanium (nitinol) single wire braid construction
- Compliant, closed-cell design
- Deployable and retrievable by a single operator
- Sterile and non-pyrogenic
- Packaged as a single unit with introducer sheath and detachable push wire
- Radiopaque markers: Distal RO Marker, Proximal RO Marker, Device Exit Marker, Distal Markers, Helical Markers, Proximal Markers
- Outer diameters (OD): 2.0 mm to 5.5 mm depending on model
- Undeployed lengths: Various from 12 mm to 76 mm (e.g., LVIS: 12-76 mm; LVIS Jr.: 13-46 mm)
- Total length includes flared ends: Working Length + 4 mm (2 mm each side)
- Fully expanded diameters: Up to 5.5 mm
- Free area percentages: 71% to 85% depending on model and OD
- Compatible microcatheters: Headway® 21 (0.021" ID) for LVIS; Headway® 17 (0.017" ID) or Scepter™ C/XC (0.0165" ID) for LVIS Jr.
- MR Conditional: 1.5T or 3T, max SAR 2 W/kg, temperature rise up to 3.6°C, artifact ~4 mm
- Single use only, sterilized by E-Beam irradiation
- No latex or PVC materials
- Foreshortening up to 60% upon deployment
- Recapturable up to ~75% deployment (proximal markers 3 mm proximal to microcatheter distal marker)
- Maximum redeployment: 3 times
Description
The MicroVention Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. device is a self-expanding nickel titanium, single wire braid, compliant, closed-cell design that can be deployed and retrieved by a single operator. The LVIS/LVIS Jr. device is sterile and non-pyrogenic and is packaged as a single unit with an introducer sheath and a detachable push wire.