FDA clears limb-saving vascular device

FDA clears limb-saving vascular device

The U.S. Food and Drug Administration (FDA) has cleared a vascular shunt that can help save the arms and legs of soldiers critically injured in combat. The Temporary Limb Salvage Shunt (TLSS) received approval in just one week, after an accelerated review process 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, MD, director of the FDA’s Center for Devices and Radiological Health. “The 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 a self-sealing elastomer membrane that permits drugs to be injected directly into the shunt without loss of blood. It also has beveled ends to facilitate quick and effective placement within the severed blood vessel and graduated markings that provide visual confirmation of proper placement. Extra reinforcement in the center of the device enables it to be cut to a shorter length if necessary.

For more information, visit the FDA Web site: www.fda.gov


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