Scepter™ Mini Indications, Safety, and Warnings

Indications for Use

Indications for Use - US:

The Scepter™ Mini Occlusion Balloon Catheter is intended for use in the peripheral and neuro vasculature where temporary occlusion is desired. The balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheter also offers balloon assisted embolization of intracranial aneurysms.

For use in the peripheral vasculature for the delivery of diagnostic agents, such as contrast media, that have been approved or cleared for use in the peripheral vasculature and are compatible with the inner lumen of the Scepter™ Mini Occlusion Balloon Catheter.

For neurovascular use for the delivery of diagnostic agents, such as contrast media, and liquid embolic agents that have been approved or cleared for use in the neurovasculature and are compatible with the inner lumen of the Scepter™ Mini Occlusion Balloon Catheter.

Indications for Use - other regions:

The Scepter™ Mini Occlusion Balloon Catheter is intended for use in the peripheral and neuro vasculature where temporary occlusion is desired. The balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheter also offers 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 lumen of the Scepter™ Mini Occlusion Balloon Catheter.