Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction

Primary Endpoints:

- Safety: Death or stroke in downstream territory to 180-days post-procedure

- Technical Success: Device placement success and ability to retain coils at the time of
the index procedure

- Rate of aneurysm occlusion at Day zero (0) and 180 days

Additional Evaluations to 180-days and at 365-day follow up:

- Rate of aneurysm occlusion at 365 days

- Device movement or migration

- Stenosis

- Rate of incidence of new neurological deficits

- Complication rate (neurological and non-neurological)

Inclusion Criteria:

- Patient who presents with an angiographically confirmed, wide neck intracranial
aneurysms located at a bifurcation of the basilar artery or carotid terminus artery

- The target aneurysm is in a vessel with a diameter of 2.7 mm to 4.5 mm.

- The patient is 18 years or older at the time of consent

- The patient has signed the IRB/EC approved informed consent form

- In the opinion of the physician, placement of the PulseRider is technically feasible
and clinically indicated

- Subject has mental capacity and is willing and able to comply with protocol
requirements and follow-up

Exclusion Criteria:

- Unstable neurological deficit (condition worsening within the last 90 days)

- Subarachnoid Hemorrhage (SAH) within the last 60 days

- Irreversible bleeding disorder

- mRS score ≥3

- Patient has another aneurysm which, in the Investigator's opinion, will require
treatment within the follow up period (365 days)

- Platelet count < 100 x 103 cells/mm3

- Inability to tolerate, adverse reaction or contraindication to taking aspirin or
clopidogrel

- A history of contrast allergy that cannot be medically controlled

- Known allergy to nickel

- Relative contraindication to angiography (e.g., serum creatinine > 2.5 mg/dL)

- Woman with child-bearing potential who cannot provide a negative pregnancy test

- Evidence of active infection

- Other conditions of the heart, blood, brain or intracranial vessels that carry a high
risk of neurologic events

- Evidence of disease or condition expected to compromise survival or ability to
complete follow-up assessments during the 365-day follow-up period

- Extracranial stenosis greater than 50% in the parent artery requiring access to the
lesion

- Intracranial stenosis greater than 50% in the treated vessel

- Extreme vessel tortuosity that prohibits appropriate control of the micro-guide wire
and/or the PulseRider delivery wire