Temporary Salvage Shunt Approved by FDA

A shunt that connects the ends of severed blood vessels and restores blood flow to injured limbs earned Food and Drug Administration approval last week.

"The device offers surgeons a new tool to potentially avoid the need for limb amputation following traumatic injury," Dr. Daniel Schultz, the director of the FDA's Center for Devices and Radiological Health said in an FDA statement announcing the approval.

The device can be implanted on the battlefield and other remote areas to temporarily maintain blood flow to injured limbs until the victim can be transported to a surgical facility. That can "help save the limbs of soldiers critically injured in combat, as well as individuals in other trauma settings and emergency situations," according to the FDA statement. Because of the critical need for the device, the FDA's division of cardiovascular devices worked closely with the manufacturer, allowing the agency to review and approve the device in only 1 week.

The Temporary Limb Salvage Shunt (TLSS) has been used successfully outside the United States and is the first device approved for treating these types of injuries, according to the FDA. The Scottish company Vascutek manufactures the TLSS.

The shunt's self-sealing elastomer membrane makes it possible to inject drugs directly into the shunt without blood loss. Beveled ends facilitate placement within the severed blood vessel, and graduated markings provide visual confirmation that the device has been implanted properly, the statement said.