FDA approved this device under the Humanitarian Device Exemption (HDE) program. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Onyx® Liquid Embolic System (Onyx® HD-500)
Manufacturer: ev3 Neurovascular
Address: 9775 Toledo Way, Irvine, CA 92618
Approval Date: April 11, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/h060003a.pdf
What is it? The Onyx® Liquid Embolic System (Onyx® HD-500) is an artificial material used to block blood flow into aneurysms. The material is used to fill the aneurysm space, or pocket, and prevent the aneurysm from rupturing or increasing in size.
How does it work?
The Onyx® Liquid Embolic System (Onyx® HD-500) is injected through a thin hollow tube (a catheter) into the blood vessels of the brain at the location of the aneurysm. Upon contact with blood, the material solidifies so that the flow of blood into the aneurysm is blocked.
When is it used? Aneurysms in the brain may rupture and cause bleeding into the surrounding brain tissue. In order to prevent such bleeding, it may be necessary to fill the aneurysm with material to cause walling off of the aneurysm space. Onyx® Liquid Embolic System (Onyx® HD-500) is used in the treatment of intracranial, saccular, sidewall aneurysms that present with a wide neck (≥ 4 mm) or with a dome-to-neck ratio < 2 that are not amenable to treatment with surgical clipping.
What will it accomplish? It may block off the aneurysm space and thereby prevent the aneurysm from rupturing.
When should it not be used? It should not be used by physicians who have not had adequate training. Physicians should contact an ev3 Neurovascular sales representative for information on training courses.
SSPB and Labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=h060003