Critical Limb-Saving Vascular Device Cleared
MedSun: Newsletter #12, February 2007

On February 9, 2007, FDA cleared for U.S. marketing a vascular shunt, a medical device that can help save the arms and legs of soldiers critically injured in combat as well as individuals in other trauma settings and emergency situations. The Temporary Limb Salvage Shunt (TLSS), made by Vascutek Ltd. (Renfrew, Scotland), was reviewed by FDA in less than 1 week because of the critical need for such a device.

"This device offers surgeons a new tool to potentially avoid the need for limb amputation following traumatic injury," said Daniel Schultz, M.D., Director of FDA’s Center for Devices and Radiological Health. "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."

The device works by connecting together the ends of a severed blood vessel, providing a bridge or shunt around the damaged area and restoring blood flow to the injured limb. It can be implanted on the battlefield and other remote areas to bypass damaged blood vessels and temporarily maintain blood flow to the injured limb until the patient can be transported to a surgical facility.

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