A plastic shunt that can temporarily rejoin the severed blood vessels of soldiers wounded on the battlefield won federal approval Friday, following an expedited review.
Citing what it called a critical need for the shunt, the Food and Drug Administration took less than a week to review and clear for marketing the Temporary Limb Salvage Shunt. The FDA did so following consultations with the U.S. Air Force, which had been approached by the device’s manufacturer. Similar reviews typically take 60 to 90 days.
Lt. Col. Todd E. Rasmussen, an Air Force vascular surgeon who helped champion the shunt, said one or two soldiers a week wounded in Iraq or Afghanistan could benefit from the device.
For most, it won’t be a matter of saving a limb outright but rather salvaging the quality of a wounded leg or arm, Rasmussen said. “By that, I mean the muscles work better,” he added.
Since the start of the Iraq war, more than 500 soldiers have lost limbs, many to injuries suffered in roadside bombings.
“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,” FDA devices chief Dr. Daniel Schultz said.
Temporary bridge around a wound
The tubelike device is designed to connect the two ends of a severed blood vessel, providing a temporary bridge or shunt around a wound to restore blood flow to an injured limb, the FDA said. It’s approved for both military and civilian use as a stopgap measure until a trauma victim can undergo surgery.
The Temporary Limb Salvage Shunt is made by Vascutek Ltd., of Renfrew, Scotland. Its parent company is Japan’s Terumo Corp.
For now, Vascutek is giving away the shunts to the military to evaluate, said Mac Ritchie, vice president of U.S. subsidiary Vascutek USA. It has no immediate plans to market them for civilian use, he added.
A plastic shunt that can temporarily rejoin the severed blood vessels of soldiers wounded on the battlefield won federal approval Friday, following an expedited review.
Citing what it called a critical need for the shunt, the Food and Drug Administration took less than a week to review and clear for marketing the Temporary Limb Salvage Shunt. The FDA did so following consultations with the U.S. Air Force, which had been approached by the device’s manufacturer. Similar reviews typically take 60 to 90 days.
The tubelike device is designed to connect the two ends of a severed blood vessel, providing a bridge or shunt around a wound to restore blood flow to an injured limb, the FDA said. It’s meant for temporary use in soldiers and other trauma victims who have suffered critical injuries to their arms or legs.
Spared from amputation
The shunt may save injured limbs from amputation, since it can be implanted on the battlefield to maintain blood flow until a wounded soldier undergoes surgery, FDA officials said. Since the start of the Iraq war, more than 500 soldiers have lost limbs, many to injuries suffered in roadside bombings.
“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,” FDA devices chief Dr. Daniel Schultz said.
The Temporary Limb Salvage Shunt is made by Vascutek Ltd., of Renfrew, Scotland. Its parent company is Japan’s Terumo Corp.
