Elana Device for Intracranial Artery Bypass Gets FDA Nod

Performing an artery bypass in the brain typically requires shutting off blood flow, potentially leading to a stroke in some patients. Based on a technology developed at UMC Utrecht, Elana, also out of Utrecht, The Netherlands, just received FDA Humanitarian Use Device approval for its commercialized product called ELANA (Excimer Laser Assisted Non-Occlusive Anastamosis) Surgical Kit, a tool that allows neurosurgeons to reroute blood flow around an aneurysm or a tumor without stopping the flow of blood.

To create the bypass, a surgeon sutures the ring and a section of replacement blood vessel onto the surface of the affected artery. Once attached, the surgeon tunnels the tip of the laser handpiece down the open end of the replacement blood vessel until the tip of the laser touches the ring.
The laser then cuts a circular hole in the affected artery, and suction removes the cut tissue. The process is repeated with a second replacement blood vessel. Once both replacement blood vessels are in place, the open ends of the two replacement blood vessels are sutured together to complete the path around the aneurysm or tumor.

Press release: FDA approves device to maintain blood flow during artery bypass brain surgery
Product page: Elana Surgical Kit
Elana Surgical Kit product brochure…