Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil

This is a prospective, multi-center study of patients treated in accordance with the cleared
indications for the Penumbra SMART CoilTM System (Smart), Penumbra Coil 400TM (PC 400), and
Penumbra Occlusion DeviceTM (POD). Data for each patient are collected in accordance with the
standard of care at each participating hospital through one-year follow-up. Approximately
1,000 patients with intracranial aneurysms or other malformations treated by the SMART CoilTM
System at up to 100 centers will be enrolled. It is anticipated patient enrollment will take
3 years. All patients are to be assessed in accordance with the standard of care at each
participating hospital through one year follow-up.

Inclusion Criteria:

Patients enrolled in this study must sign Informed Consent and be treated according to the
cleared indications for the Smart, PC 400, and POD, which include the embolization of:

- Intracranial aneurysms

- Other neurovascular abnormalities such as arteriovenous malformations and
arteriovenous fistulae

Exclusion Criteria:

- Life expectancy less than one year

- Smart, PC 400, or POD account for less than 75% of total number of coils opened

- Participation in another clinical investigation that could confound the evaluation of
the study device