First Non-Tourniquet Device to Treat Amputations Cleared

The U.S. Food and Drug Administration (FDA) has given new critical indications to the Combat Ready clamp made by Combat Medical Systems of Fayetteville, N.C. The device is the first of its kind to be approved to treat unmanageable amputations and pelvic wounds not addressable with standard limb tourniquets.

The Combat Ready clamp is a vise-like tourniquet now approved for use on all five anatomical junctions where life-threatening hemorrhage can occur in the result of such actions as roadside and terrorist bombings.

Uncontrolled bleeding is the leading cause of preventable death in combat and remains the top focus of tactical medicine.

Approximately 25 percent of potentially survivable deaths are due to uncontrolled junctional bleeding. According to an upcoming study in the American Journal of Emergency Medicine, more than 800 U.S. military personnel have been hospitalized with these types of junctional injuries during the recent wars in Iraq and Afghanistan. More than 150 personnel suffered from upper extremity injuries, 25 of whom died of their wounds. The FDA 510(k) clearance will allow the Combat Ready clamp to be put to use in every compressible, junctional emergency situation.

Combat Medical Systems worked extensively with the U.S. Army’s Institute for Surgical Research (USAISR) in San Antonio, Texas, and with the Wake Forest University Baptist Medical Center in Winston Salem, N.C., to ensure the device’s clinical efficacy.

“The Combat Ready clamp is the first device available to treat junctional hemorrhage of the upper extremity on the battlefield or anywhere else,” said John Kragh, M.D., of the U.S. Army. “We in the military also continue to be impressed with their team which includes Wake Forest University in their commitment to the best care for these casualties.”

According to the company, the Committee on Tactical Combat Casualty Care recommended the device, which applies in seconds. It has already shown life saving success in limited use in Afghanistan as well as multiple Life Flight cases in the U.S.

“Everyone at Combat Medical Systems is excited about this recent news,” said Chris Murphy, vice president of research and development at the company. “This has certainly been a team effort. The support we have received from the USAISR and Wake Forest University has been invaluable in our efforts to deliver this on-of-a-kind device. But it is the early adopters, the military leaders and most importantly our great military medics and corpsman that serve our fallen every day that deserve the most credit.”

Combat Medical Systems makes products for trauma in harsh situations, such as battlefields.