The ELANA (Excimer Laser Assisted Non-Occlusive Anastamosis) surgical kit allows neurosurgeons to create a bypass without shutting off the blood flow and consists of a small platinum ring and a hand piece connected to a surgical laser and suction tubing.
The FDA approved the ELANA surgical kit as a Humanitarian Use Device, which is designed to treat or diagnose a disease or condition in fewer than 4,000 people in the US each year.
The clinical data in support of approval demonstrated that a bypass created using the ELANA kit had the same types and similar incidences of adverse events reported in the medical literature as conventional bypass procedures.
