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FDA Fast-tracks Medical Device Designed for U.S. Military

A medical device to save the arms and legs of U.S. military personnel from amputation became the first of its kind to win U.S. marketing clearance by the U.S. Food and Drug Administration (FDA).

The military hopes the Temporary Limb Salvage Shunt will reduce the number of arm and leg amputations and improve the quality of life of other patients who suffer injuries, according to Air Force Lieutenant Colonel Todd Rasmussen,Chief of Military Vascular Surgery at Wilford Hall Medical Center in San Antonio, the Air Force's largest medical facility. The military plans to use the devices in Iraq in one or two soldiers per week.

The United States is the first country to grant clearance for use of the device, said Mac Ritchie, Vice-President, Vascutek Ltd. The device is designed and manufactured by Renfrew, Scotland-based Vascutek Ltd., a division of Terumo Corporation.

"There was a critical need for this device,” said David Buckles, Chief of FDA's peripheral device branch. "We think it has a chance of working very well and improving the chances of salvaging a limb that has suffered this sort of traumatic injury.”

The device works by connecting 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.

Six percent of the 14,120 soldiers injured in Iraq between March 2003 and August 2005 — equivalent to 28 soldiers per month — had arm or leg amputations, according to the AEI-Brookings Joint Center for Regulatory Studies in Washington.

Vascutek, Ltd., a wholly owned subsidiary of Terumo Corporation, Japan, is one of the world's leading designers, manufacturers and marketers of vascular products for the treatment of cardiovascular disease. Its U.S. operations are based in Ann Arbor, Michigan. It is one of a family of Terumo companies focused on cardiac and vascular disease, along with Terumo Cardiovascular Systems Corporation, developer and manufacturer of cardiac surgery devices, and Terumo Heart, developer of a ventricular assist device. For more information, visit www.vascutek.com

Terumo Corporation is a premier global medical company with 2006 annual sales in excess of $2.1 billion. For more information, visit www.terumo.com.

Terumo Cardiovascular Systems Corporation manufactures and markets products for cardiac surgery. It is headquartered in Ann Arbor, Michigan with American manufacturing operations in Ann Arbor, as well as Elkton, Maryland; Ashland,Massachusetts; and Tustin, California. For more information,visit www.terumo-cvs.com