Scepter C™ & Scepter XC™ Indications, Safety, and Warnings

Indications for Use

Indications for Use (USA)

For use in the blood vessels of the peripheral and neurovasculature where temporary occlusion is desired. These catheters offer a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow and for balloon assisted embolization of intracranial aneurysms.

For use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials.

For neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials, that have been approved or cleared for use in the neurovasculature and are compatible with the inner diameter of the Scepter C ™ or Scepter XC™ Balloon Catheter.

Indications for Use (Europe, Middle East, Africa)

The Terumo Neuro Scepter C™ and Scepter XC™ Occlusion Balloon Catheters are intended for:

For use in the peripheral and neuro vasculature where temporary occlusion is desired. The balloon catheters provide temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheters also offer balloon assisted embolization of intracranial aneurysms.

For use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents such as embolization materials.

For neurovascular use for the infusion of diagnostic agents such as contrast media, and therapeutic agents, such as embolization materials, that have been approved or cleared for use in the neurovasculature and are compatible with the inner diameter of the Scepter C™ or Scepter XC™ Balloon Catheter.

Indications for Use (China, Asia Pacific, Latin America)

The Scepter C™ and Scepter XC™ Occlusion Balloon Catheters are intended:

For use in the peripheral and neuro vasculature where temporary occlusion is desired. The balloon catheters provide temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheters also offer balloon assisted embolization of intracranial aneurysms.

For use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents such as embolization materials.

For neurovascular use for the infusion of diagnostic agents such as contrast media, and therapeutic agents, such as embolization materials, that have been approved or cleared for use in the neurovasculature and are compatible with the inner diameter of the Scepter C ™ or Scepter XC™ Balloon Catheter.

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.