Elana, a corporate spin-off from the University Medical Centre Utrecht, the Netherlands, has obtained the US Food and Drug Administration (FDA) approval for its neurosurgery device Elana Surgical KitHUD.
Elana said 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.
The patented Elana Surgical KitHUD is currently used in neurosurgery in numerous European countries as well as in Canada.
In the US 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.
FDA Center for Devices and Radiological Health Jeffrey Shuren director said the Elana Surgical Kit may help those with a rare condition for whom there previously was no treatment option.
Hofstra University School of Medicine Neurological Surgery associate professor David Langer believes that the technology holds promise not just in neurosurgery but in the area of coronary bypass, transplant and peripheral vascular surgery as well.
Elana CEO Felix von Coerper said with approval from the FDA and with the potential to leverage their technique and intellectual property for other vascular applications they are looking forward to build a sustainable and fast growing business.