DMI/FDA/2.0.1/LVIS
Low-Profile Visualized Intraluminal Support (LVIS), Low-Profile Visualized Intraluminal Support (LVIS) Jr., and Low-Profile Visualized Intraluminal Support (LVIS) EVO, Terumo Neuro - Sim&Size v2.0.1
Indication for use
LVIS and LVIS Jr (P170013)
The LVIS is 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.
LVIS EVO (P170013/S004)
The LVIS device is 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.


