LVIS™ EVO™ Indications, Safety, and Warnings
See Instructions for Use for a complete list of warnings, precautions, and contraindications
Indications for Use
USA
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 diameter ≥ 2.0 mm and ≤ 4.5 mm.
EMEA and CHAPLA
The LVIS™ EVO™ Device is intended for use with embolic coils for the treatment of intracranial neurovascular diseases.
The products may not be approved in all regions. The orders will be taken only in the regions where the product is approved by local regulatory authorities, as required.
