125 Final Results of the ELANA FDA-IDE Study on High Flow Cerebral Bypasses for Surgical Treatment of Anterior Circulation Aneurysms

Complex intracranial aneurysms and tumors may require high flow cerebral bypasses for safe treatment. All previous studies on such high flow bypasses have been retrospective single institution case series with complication rates and outcomes that may be inherently biased. Here we present results from the first prospective, multicenter international trial on high flow bypasses using the Excimer Laser Assisted Nonocclusive Anastomosis (ELANA) system.

A total of 8 centers in the US, Canada, and Europe participated in an FDA-IDE trial. All patients required flow replacement or protective bypass for safe treatment of giant/complex aneurysms or tumors; and additionally in Europe, for flow augmentation for bilateral carotid occlusion.

A total of 46 patients were enrolled, with a mean age of 54.2 (R: 17–76 yrs); 15 males, and 31 females. A subgroup of 35 patients who received a permanent ELANA bypass for anterior circulation...