HydroSoft™ 3D & HydroSoft™ Helical Indications, Safety, and Warnings
See Instructions for Use for a complete list of warnings, precautions, and contraindications
Indications for Use
The HydroCoil™ Embolic System (HES) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
The device should only be used by physicians who have undergone pre-clinical training in all aspects of HES procedures as prescribed by Terumo Neuro.
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.