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Dutch Medical Device Company Elana receives FDA Approval for Lifesaving Device for Cerebral Bypass Surgery

Posted Mar 26 2011 12:05am

This is for a bypass procedure of the brain and they hope to move into the coronary image field in the future.  This is one bypass I hope I never need.  This is a catheter surgical kit that places an implant in the brain for the bypass.  The surgeon can also stop a procedure at any state of surgery. 

The website has a video that explains a bit more about the procedure.  BD 

COLUMBIA, Md.--( BUSINESS WIRE )--Dutch medical device manufacturer, Elana bv, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for a humanitarian device exemption (HDE), enabling a lifesaving cerebral bypass. Elana bv is a corporate spin-off from the University Medical Centre Utrecht, the Netherlands. image

“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. The company expects that annually a thousand patients worldwide are eligible to be treated with the device.

The patented Elana Surgical KitHUD is currently used in image neurosurgery in numerous European countries as well as in Canada. In the United States the device has been used under a clinical study in St. Luke’s Roosevelt Hospital in New York, University of Illinois at Chicago, University of Texas Southwestern Medical School and the University of Arkansas for Medical Sciences.

Elana produces a disposable laser catheter and an implant, through image which blood vessels can be connected and subsequently opened. Surgeons are able to use the Elana Surgical KitHUD for constructing a vascular bypass without any interruption of the blood flow on patients of 13 years and older who have an aneurysm or tumor at the skull base. “It changes the concept of bypassing fundamentally, making it more safe for patients,” states Prof C.A.F. Tulleken, Emeritus Professor and former Chairman of Neurosurgery UMC Utrecht, The Netherlands, and, with his team, inventor of this concept.


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