Onyx Liquid Embolic Systems - Prosthesis, internal, embolization, intravascular

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

MAH:

Medtronic Australasia Pty Ltd

class:

Class III

manufactured_by:

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

therapeutic_area:

35449 - Prosthesis, internal, embolization, intravascular

therapeutic_indication:

Liquid Onyx is delivered through a DMSO primed microcatheter placed within a feeding pedicle of an AVM or an aneurysm. The DMSO priming volume separates Onyx from blood, saline or contrast media within the cathteter lumen that may cause early precipitation and catheter occlusion. Onyx material is injected at a slow rate. Solidification of the material begins immediately upon injection, beginning as a "skin" on the outside of the mass./ Total solidification occurs within minutes. Embolization of intracranial aneurysms and lesions in the peripheral and neurovasculature including arteriovenous malformations and hypervascular tumours.

authorization_status:

A

authorization_date:

2008-04-23