Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study
Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study
The purpose of this study is to evaluate the safety of the Apollo™ Onyx™ Delivery
 Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain arteriovenous
 malformation (AVM) embolization procedures.
This study is a prospective, single-arm, multicenter, post-market safety evaluation of
 subjects indicated for embolization of brain AVMs with the study device. The study device was
 developed to potentially minimize the side effects of catheter retainment and increased
 procedural risk associated with alternative methods necessary for removing entrapped
 catheters. In the event of catheter retainment, using the Apollo™ Onyx™ Delivery
 Microcatheter versus any a standard catheter represents leaving behind a 1.5 - 3.0 cm long
 detachable tip in the Onyx™ Onyx™ Delivery Microcatheter cast versus an average 165 cm long
 catheter in the vasculature.
Inclusion Criteria:

 -  The Subject or Subject's legally authorized representative has signed and dated an
 informed consent form.

 -  The Subject has a confirmed diagnosis of a brain AVM.

 -  The Subject is clinically and neurologically stable for a minimum of 48 hours prior to
 embolization.

 -  The Subject has a life expectancy of at least 1 year.

 -  The Subject agrees to and is capable of completing all study-required procedures.

 Exclusion Criteria:

 -  Current participation in another investigational drug or device study that evaluates
 treatments for brain AVMs or other cerebrovascular disease.

 -  The Subject has a bleeding disorder.

 -  The Subject is not a candidate for the use of vasodilators.