Medical device developer Combat Medical Systems has received the Food and Drug Administration’s marketing go-ahead on a device developed to control bleeding from combat injuries.
The Fayetteville company’s device, called the Combat Ready Clamp, now has additional FDA clearance for use treating injuries injuries sustained from combat situations, such as roadside bombs. Injuries to limbs or the torso can result in what’s called junctional bleeding, bleeding in areas where it’s difficult to apply a standard tourniquet to stop the bleeding. Combat Medical Systems says approximately 25 percent of potentially survivable deaths are due to uncontrolled junctional bleeding.
The Combat Ready Clamp is a vise-like tourniquet that can be applied to the injured area. The company worked with the U.S. Army’s Institute for Surgical Research in San Antonio, Texas and the Wake Forest University Baptist Medical Center to test the product’s clinical efficacy. According to FDA records, Combat Medical Systems first received FDA clearance on the Combat Ready Clamp in 2010 for use treating bleeding in the groin area. The clamp’s constant pressure allows medical personnel to attend to others and also controls a difficult bleed until the soldier can be evacuated for further treatment.
Combat Medical Systems isn’t the only company pursuing this application. SAM Medical Products, a Wilsonville, OR company, received FDA clearance in March for its SAM Junctional Tourniquet, a device intended to control bleeding in the groin.
Combat Medical Systems was founded in 2008 by former military medical personnel. The company is located near Fort Bragg.
