Device Approved to Continue Blood Flow During Brain Surgery
FRIDAY March 11, 2011 -- A device that permits the rerouting of blood flow during surgery to treat a brain aneurysm or tumor in people at greater risk of stroke has been approved by the U.S. Food and Drug Administration.
The Excimer Laser Assisted Non-Occlusive Anastamosis (ELANA) Surgical Kit makes it possible for surgeons to bypass the aneurysm or tumor without clipping the affected artery and temporarily ending blood flow, the agency said in a news release.
About 1,000 people who have brain bypass surgery each year would be at higher-than-normal risk of stroke if the artery were clipped and blood flow stopped, the agency said. These patients -- 13 and older -- often have a weakened, enlarged area in a brain artery called a cerebral aneurysm, or a tumor at the base of the skull.
The ELANA kit was approved under the FDA's "Humanitarian Use Device" rules, meaning it's designed to treat or diagnose a condition that affects fewer than 4,000 people each year in the United States. Qualifying manufacturers must show that the device's benefits outweigh its risks, and that no similar device is already available.
The ELANA kit should not be used if the patient shows hardening of the arteries (arteriosclerosis) or artery calcification, the FDA warned.
The device is made by Elana, based in the Netherlands.
To learn more about brain bypass surgery, visit HeartHealthyWomen.org.
Posted: March 2011