FDA Okays Marketing of Multi-Sponge Wound Dressing to Control Bleeding

The U.S. Food and Drug Administration approved the marketing of a special bandage that controls bleeding in wounds received in battle.

The FDA gave a green signal to RevMedX's XSTAT, a multi-sponge wound dressing, to control bleeding from certain types of wounds in areas where a tourniquet cannot be placed such as the groin or armpit.  Approved for military use only, XSTAT a temporary dressing can be used for nearly four hours and gives ample time for the patient to get proper medical care.

Statistics according to the U.S. Army Medical Department, Medical Research and Material Command reveal that since World War II, over 50 percent of combat deaths occurred due to exsanguinating haemorrhage or bleeding out. And out these, half of them could have been saved if appropriate care was offered on time.

XSTAT has three syringe-style applicators. These applicators have 92 percent compressed, cellulose sponges with a spongy layer. These spongy absorbents expand to fill the wound cavity nearly 20 seconds after exposure to water from blood or bodily fluid.

This constructs a temporary physical barrier to the blood flow.  Based on the size and depth of the wound the number of sponges needed for effective hemorrhage control also differs. Only three applicators can be used on a patient. These tablet-shaped sponges are nearly 9.8 millimeters wide and 4 to 5 millimeters in length. They can take in 3 milliliters of blood or body fluid. Applicator with 92 sponges can take in 300 milliliters of fluid.

These sponges cannot be absorbed by the body and federal agency cautions that the sponges must be withdrawn before the closure of the wound. To make the process of removal of every sponge more easy, each sponge has a marker visible via X ray.

"XSTAT is a novel device that can be rapidly deployed, providing fast-acting hemorrhage control to stabilize a wounded patient for transport," said Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health. "This will be an important new treatment option for our nation's military to treat injured soldiers who may not be in close proximity to a medical facility."

The multi sponge wound dressing was reviewed through nevo classification process.