Background It is estimated that approximately 1-6% of the adult population harbor cerebral aneurysms1. Annual risk of rupture of an intact intracranial aneurysm is estimated to be around 1.9%. If an intracranial aneurysm ruptures, blood leaks into highly sensitive subarachnoid space around the brain, resulting in a subarachnoid hemorrhage (SAH), which is a known major risk factor for stroke. Furthermore, SAH is associated with high mortality rates; close to 50% of ruptured aneurysms resulting in death within 6 months. Even if an intracranial aneurysm does not rupture, studies have shown that approximately 2.2-23% of patients with unruptured aneurysms may eventually experience a rupture. The Penumbra Smart Coil System, a new generation of detachable coils, was developed to improve the delivery system and improve clinical outcomes of aneurysm treatments. It incorporates new technology into the individual coils itself, such as becoming progressively softer as it is deployed, improve stretch resistance, and creates accurate complexes, helical shapes, and hyperbolic shapes.

Methods Prospective, single center registry of patients treated in accordance with clear indications for the new Penumbra SMART CoilTM System, which include the Penumbra Coil 400 (PC 400) and Penumbra Occlusion DeviceTM (POD). 189 consecutive patients with intracranial aneurysms or other malformations who were treated by the SMART COILTM System was enrolled into this study. Data for each patient was collected in accordance with the standard of care through 1-year follow-up. Recorded the coils’ ability to achieve adequate occlusion, number of times re-access with guidewire was required due to catheter, procedural device- related serious adverse events immediate post- procedure, and retreatment at follow-up. The Inclusion Criteria include intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and fistulae. The Exclusion Criteria include life expectancy less than one year. SMART coils accounting for less than 75% of the total number of coils utilized for the procedure.

Results Total of 189 cases and 841 coils were used. The average height, width, and depth of the aneurysms were 5.542 mm, 4.586 mm, and 4.465 mm, respectively. The average volume of each aneurysm was 267.9 mm3. 80 of the aneurysms were ruptured, which is 42.3% of total cases. 22.6% of cases had severe tortuosity at cavernous curve, while 49.5% had moderate tortuosity. Coils achieved an average packing density of 38.3%. 14.5% of cases used stents during the procedures and of those, 14.8% of them were jailed. Among the cases that had follow-ups performed by the time of this study 76% had Class I Raymond Roy occlusion, while 21% and 2.6% had Class II and IIIb Raymond Roy occlusion.

Conclusion This study concludes that is SMART coil system is safe and efficacious for the use in Endovascular treatment of intracranial aneurysms. The smart coil system is promising in the treatment of wide spectrum of intracranial aneurysms. The result of follow up angiographic data should reflect the high packing density and will be published when completed.

Disclosures S. Khairandish: None. S. Pakbaz: None. M. McManus: None. G. Ammirati: None.