-- Scott Roberts
FRIDAY, March 11 (HealthDay News) -- 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
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
The ELANA kit should not be used if the patient shows hardening
of the arteries (arteriosclerosis) or artery calcification, the FDA
The device is made by Elana, based in the Netherlands.
To learn more about brain bypass surgery, visit
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