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The Honolulu Advertiser
Posted on: Sunday, February 18, 2007

FDA OKs battlefield life-saver

Associated Press

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Food and Drug Administration: www.fda.gov

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WASHINGTON — A plastic shunt that can temporarily rejoin the severed blood vessels of soldiers wounded on the battlefield has won federal approval after an expedited review urged by the military.

Citing the critical need for the shunt, the Food and Drug Administration took less than a week to review and clear for marketing the Temporary Limb Salvage Shunt. The FDA did so on Feb. 9 after consultations with the Air Force.

The tubelike device is designed to connect the two ends of a severed blood vessel, providing a bridge or shunt around a wound to restore blood flow to an injured limb, the FDA said. It's meant for temporary use in soldiers and other trauma victims who have suffered critical injuries to their arms or legs.

The shunt may save injured limbs from amputation, since it can be implanted on the battlefield to maintain blood flow until a wounded soldier undergoes surgery, FDA officials said. Since the start of the Iraq war, more than 500 soldiers have lost limbs, many to injuries suffered in roadside bombings.

"This device has been used successfully by other countries, and is particularly important to serve our men and women in the armed forces who are seriously injured in combat," FDA devices chief Dr. Daniel Schultz said.

The Temporary Limb Salvage Shunt is made by Vascutek Ltd., of Renfrew, Scotland. Its parent company is Japan's Terumo Corp.