SOFIA™ Indications, Safety, and Warnings
See Instructions for Use for a complete list of warnings, precautions, and contraindications
Indication for Use & Intended Purpose
Indications For Use - NA
The SOFIA™ Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA™ Catheter can be used to facilitate introduction of diagnostic or therapeutic devices. The SOFIA™ Catheter is not intended for use in coronary arteries.
Indications For Use - EMEA
The SOFIA™ Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA™ Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. The SOFIA™ Catheter is not intended for use in coronary arteries. Moreover, the SOFIA™ Catheter is intended for use in removal/aspiration of emboli and thrombi from selected blood vessels in the arterial system, including the peripheral and neuro vasculatures.
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.
