FDA Grants Dutch Device Maker HDE for Cerebral Bypass Device

Dutch medical device manufacturer, Elana bv, announced 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.

“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 is used in neurosurgery in European and 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 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,” said Professor C.A.F. Tulleken, emeritus professor and former chairman of Neurosurgery UMC Utrecht, The Netherlands, and, with his team, inventor of this concept.

Currently, R&D efforts are ongoing to apply the technique in other surgical fields with substantially bigger market potential. David Langer M.D., associate professor of Neurological Surgery at Hofstra University School of Medicine, and the first neurosurgeon to use the device in the United States, believes that this technology holds promise not just in neurosurgery but in the area of coronary bypass, transplant and peripheral vascular surgery as well.

In order to facilitate market introduction in the United States and further research and development activities, Elana recently raised additional capital. Felix von Coerper, CEO of the privately owned company, is optimistic: “With approval from the FDA and with the potential to leverage our technique and intellectual property for other vascular applications we are looking forward to build a sustainable and fast growing business.”