The FDA granted dutch medical device maker Elana a humanitarian device exemption for its Elana Surgical KitHUD, which is used for vascular bypass during neurosurgery. The device was already in use in Europe and Canada.
The kit uses a laser catheter and implant to connect blood vessels for vascular bypass in patients with an aneurysm or tumor at the base of the skull. "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, in a release.
The company is continuing to search for more application of its product, which could currently treat 1,000 patients per year. Elana is focusing its research on transplant and coronary bypass patients as well as patients undergoing peripheral vascular surger.
- see the Elana release