Elana Bypass Device Receives Humanitarian Device Exemption

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Elana received U.S. Food and Drug Administration approval for its Elana Surgical KitHUD though the humanitarian device exemption program. The KitHUD enables life-saving cerebral bypass.

Surgeons can use the Elana Surgical KitHUD, which consists of a disposable laser catheter and an implant, to construct a vascular bypass without clamping the intracranial artery.

“It changes the concept of bypassing fundamentally, making it more safe for patients,” said inventor C.A.F. Tulleken, emeritus professor and former chairman of Neurology UMC Utrecht, the Netherlands.

The Elana Surgical KitHUD currently is used in neurosurgery in various European countries, as well as Canada, and is under clinical study at St. Luke’s Roosevelt Hospital in New York, N.Y., the University of Illinois in Chicago, Ill., the University of Texas Southwestern Medical School in Dallas, Tex., and the University of Arkansas for Medical Sciences in Little Rock, Ark.

Future plans include the application of the Elana Surgical KitHUD in other surgical fields that have substantially bigger market potential. David Langer M.D., associate professor of neurological surgery at Hofstra University School of Medicine in Long Island, N.Y.,was the first neurosurgeon to use the device in the United States. Langer believes the Elana Surgical KitHud can be used in areas such as coronary bypass, transplant and peripheral vascular surgery in addition to neurosurgery.

A preclinical study agreement for applications in cardiac bypass has been reached between Elana and UMC Urecht departments of Experimental Cardiology and Cardiothoracic Surgery.Elana recently raised capital to facilitate market introduction and further research and development opportunities in the United States.

“The Elana Surgical Kit may help those with a rare condition for whom there was previously no treatment option,” Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, stated.

Elana bv CEO Felix von Coerper is equally 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,” he said.

Elana, a Dutch medical device manufacturer, expects thousands of patients to be eligible for treatment with the device annually.