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March 16, 2011

Elana Receives FDA Clearance for Anastomosis Device

The US Food and Drug Administration (FDA) has approved the excimer laser assisted non-occlusive anastamosis (ELANA) surgical kit, which allows neurosurgeons to re-route blood flow around an aneurysm or tumour during bypass surgery. The device, developed by Dutch firm Elana, is indicate

By cms admin

The US Food and Drug Administration (FDA) has approved the excimer laser assisted non-occlusive anastamosis (ELANA) surgical kit, which allows neurosurgeons to re-route blood flow around an aneurysm or tumour during bypass surgery.

The device, developed by Dutch firm Elana, is indicated for use on patients at greater risk of stroke during standard bypass surgery.

It features a small platinum ring and a hand piece connected to a surgical laser and suction tubing.

The FDA approved the ELANA surgical kit as a Humanitarian Use Device, which is a device that is designed to treat or diagnose a disease affecting fewer than 4,000 people in the US each year.

FDA Center for Devices and Radiological Health director Jeffrey Shuren said that the kit may help those with a rare condition for whom there previously was no treatment option.

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