PHIL® Embolic System Pediatric IDE

Study design:The study is a prospective, single-center, single-arm, clinical study evaluating
outcomes in pediatric subjects with intracranial dural arteriovenous fistulas treated with
PHIL® device.

Study purpose: To evaluate the safety and probable benefit of MicroVention, Inc. PHIL® Liquid
Embolic material in the treatment of intracranial dural arteriovenous fistulas, alone or as
an adjunctive treatment for dAVFs.

Inclusion Criteria:

- Subject is <22 years of age

- Subject and legally authorized representative are willing and capable of complying
with all study protocol requirements, including specified follow-up period.

- Subject's legally authorized representative(s) must sign and date an IRB approved
written informed consent prior to initiation of any study procedure

- Subject has an intracranial dAVF that is deemed appropriate for embolization with PHIL
without significantly increased risk to collateral or adjacent territories, OR subject
has been previously treated with other embolic materials for dAVF.

Exclusion Criteria:

- Subject presents with an intracranial mass or is currently undergoing radiation
therapy for carcinoma or sarcoma of the head or neck region

- Subject has known allergies to DMSO (dimethyl sulfoxide), iodine or heparin.

- Subject with a history of life threatening allergy to contrast media (unless treatment
for allergy is tolerated).

- Female subject is currently pregnant.

- Subject has an acute or chronic life-threatening illness other than the neurological
disease to be treated in this study including but not limited to any malignancy or
debilitating autoimmune disease

- Subject has existing severe or advanced comorbid conditions which significantly
increase general anesthesia and/ or surgical risk

- Evidence of active infection at the time of treatment.

- Subject has a history of bleeding diathesis or coagulopathy, international normalized
ratio (INR) greater than 1.5, or will refuse blood transfusions.

- Subject weighs ≤ 2.5kg Angiographic

- Subject has severe calcification or vascular tortuosity that may preclude the safe
introduction of the sheath, guiding catheter, or access to the lesion with the
microcatheter.

- Contra-indication to DSA, CT scan or MRI/ MRA

- History of intracranial vasospasm not responsive to medical therapy

- Extra-cranial stenosis or parent vessel stenosis > 50% proximal to the target lesion
to be treated.

- Subject has a propensity to contrast induced renal injury or a potential to
nephrogenic systemic fibrosis