Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
The primary objective of this study is to gather post market data on the Penumbra SMART COIL®
 System (Smart System) in the treatment of intracranial aneurysms and other malformations.
This is a prospective, multi-center registry of patients treated in accordance with the
 cleared indications for the Smart System (Smart), Penumbra Coil 400TM (PC 400), and Penumbra
 Occlusion Device (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 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 the Informed Consent Form 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 implanted

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