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WASHINGTON: US health officials said on Friday they approved a new device that could help save the arms and legs of injured soldiers and trauma victims.
The Temporary Limb Salvage Shunt, made by Terumo Corp. of Japan's unit Vascutek Ltd., connects the ends of a severed blood vessel, providing a bridge around the damaged area and restoring blood flow to the injured limb.
The plastic device can be implanted temporarily while the patient is on the battlefield or in a remote area to temporarily maintain blood flow until the patient can be taken to a surgical facility, the FDA added.
The Food and Drug Administration said it reviewed and approved the device in less than a week because it met a critical need.
“This device offers surgeons a new tool to potentially avoid the need for limb amputation following traumatic injury,” Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said in a statement.
Mac Ritchie, vice president of Vascutek USA, said the device was developed years ago at the end of 1991 Gulf War but never sold.
When he saw reports of soldiers coming back from Iraq with limb amputations, “I realized we had something sitting on the shelf that might be reintroduced to this war,” Ritchie said in an interview.
The company approached the U.S. Air Force, which saw a need for the device and helped bring it through the FDA approval process, Ritchie said.
