LVIS™ & LVIS™ Jr Indications, Safety, and Warnings

Indications for Use

USA: The LVIS™ and LVIS™ Jr. devices systems 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.

Rx Only: Federal (USA) law restricts this device to sale by or on the order of a physician.

Canada: The LVIS™ device is intended for use with embolic coils for the treatment of wide neck (neck ≥4mm or dome to neck ratio <2), intracranial, saccular aneurysms arising from a parent vessel with a diameter of ≥ 2mm and ≤ 4.5mm that are not amenable to treatment with surgical clipping.

EMEA & CHAPLA: The LVIS™ device is intended for use with embolic coils for the treatment of intracranial neurovascular diseases.

Asian Markets: 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.