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FDA NEWS RELEASE
FOR IMMEDIATE RELEASE
FDA Clears Critical Limb-Saving Vascular Device
The U.S. Food and Drug Administration (FDA) today 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 one 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, Center for Devices and Radiological Health, FDA. "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.
The TLSS is a tube formed from two layers of plastic. The device has several features that optimize its use in a trauma situation, including a self-sealing elastomer membrane that permits drugs to be injected directly into the shunt without loss of blood; beveled ends that facilitate quick and effective placement of the device within the severed blood vessel; graduated markings that provide visual confirmation of proper device placement; and extra reinforcement in the center of the device so it can be cut to a shorter length if needed.
To facilitate this accelerated review process, the device manufacturer worked in close collaboration with FDA's Division of Cardiovascular Devices after discussion of the need for the device with the U.S. Air Force. There are currently no other devices specifically available for treating injuries of this nature.