Platinum surgical device wins FDA approval 15th March 2011
A platinum-based surgical device used to maintain blood flow during artery bypass brain surgery has won approval from the US Food and Drug Administration (FDA).
The ELANA (Excimer Laser Assisted Non-Occlusive Anastamosis) Surgical Kit allows neurosurgeons to reroute blood flow around an aneurysm or a tumour in the brains of patients at a higher risk of stroke during standard surgery.
It is comprised of a small platinum ring and a hand piece connected to a surgical laser and suction tubing.
"The ELANA Surgical Kit may help those with a rare condition for whom there previously was no treatment option," explained Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.
It is thought the kit will be of particular importance to patients under the age of 13 and older people who have an enlarged, weak area in a brain artery, tumours at the base of the skull or any other issues that could complicate surgery and increase the risk of stroke.
Manufactured by Elana, a company based in the Netherlands, the device is classed as a Humanitarian Use Device.
This means it is designed to treat or diagnose diseases or conditions affecting fewer than 4,000 people in the US every year.
Source:
FDA Approves Device to Maintain Blood Flow During Artery Bypass Brain Surgery (10/03/11)
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