Embolization implant inserter

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Medtronic Australasia Pty Ltd

Class:

Class Is

Manufactured by:

Micro Therapeutics Inc DBA ev3 Neurovascular 9775 Toledo Way, Irvine, CA, 92618 United States Of America

Therapeutic area:

43978 - Embolization implant inserter

Therapeutic indications:

The Axium Detachable Coils are intended for the endovascular embolization of intracranial aneurysms and for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae. They are also intended for arterial and venous embolization in the peripheral vasculature. The proximal end of the pusher is loaded into the Actuator which detaches the coils once it is activated. The Actuator is a hand held unit that is designed with a thumb slider. When the slider is retracted while the pusher is loaded, it releases the coil into the targeted vasculature. There are no batteries or cable sets allowing instant detachment. The Actuator does not come into contact with the patient. It is packaged separately as a sterile device for single patient use only.

Authorization status:

A

Authorization date:

2008-02-12