FDA NEWS RELEASE
For Immediate Release: March 10, 2011
Media Inquiries: Karen Riley, 301-796-4674, email@example.com
Consumer Inquiries: 888-INFO-FDA
FDA approves device to maintain blood flow during artery bypass brain surgery
Option for those at greater risk for stroke during standard bypass surgery
The U.S. Food and Drug Administration today approved a surgical kit that allows neurosurgeons to reroute blood flow around an aneurysm or a tumor in the brains of patients at greater risk of stroke during standard bypass surgery.
The ELANA (Excimer Laser Assisted Non-Occlusive Anastamosis) Surgical Kit allows neurosurgeons to create a bypass without shutting off the blood flow. It consists of a small platinum ring and a hand piece connected to a surgical laser and suction tubing.
Standard bypass surgery in the brain requires clipping the artery to halt blood flow during the procedure. The surgery is not considered safe for about 1,000 patients annually in the United States because temporarily shutting off their blood flow would put them at high risk of stroke. The group includes patients ages 13 and older who have an enlarged, weak area in a brain artery (cerebral aneurysm), tumors at the base of the skull that could impact blood flow in brain arteries, or other issues that could complicate conventional surgery.
“The ELANA Surgical Kit may help those with a rare condition for whom there previously was no treatment option,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
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.
The FDA approved the ELANA Surgical Kit as a Humanitarian Use Device, which is a device that is designed to treat or diagnose a disease or condition in fewer than 4,000 people in the United States each year. To obtain approval for humanitarian use, a company must demonstrate the safety of the device and that the probable benefit outweighs the risk of illness or injury. The company must also show that no comparable devices are available to treat or diagnose the disease or condition.
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.
A patient should not undergo laser bypass surgery using the Elana kit if the arteries show signs of arteriosclerosis or calcification at the surgery site, the walls of the affected artery are thicker than a carotid artery, or have an abnormality. Bypass surgery with the Elana should not be done on an aneurysm or on vessels other than large (> 2.5 mm), intracranial arteries.
In some cases, the laser does not completely cut through an artery wall leaving a tissue flap that potentially could block blood flow and result in an embolism. As part of the approval, the FDA required a post approval registry study to collect performance information about the kit, including flap retention rate, mortality, and stroke.
The ELANA Surgical Kit is manufactured by Elana, in Utrecht, Netherlands.