Federal (USA) law restricts this device to sale, distribution, and use by or on the order of a physician. This device should be used only by physicians with a thorough understanding of angiography and percutaneous neurointerventional procedures.
See Instructions for Use for a complete list of warnings, precautions, and contraindications.
Axium™ and Axium™ Prime detachable coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ and Axium™ Prime detachable coils are also intended for the embolization of other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Axium™ Prime (Frame) detachable coils are also indicated for arterial and venous embolizations in the peripheral vasculature.
Potential complications include, but are not limited to: