Compression Works, Inc. manufacturer of the Abdominal Aortic and Junctional Tourniquet-Stabilized (AAJT-S) device, announces a new 510(k) clearance from the FDA. This is the third 510(k) clearance granted by the U.S. Food and Drug Administration (FDA) for the AAJT-S technology.
The AAJT-S junctional tourniquet is designed to control non-compressible hemorrhages in the junctional areas of the anatomy, on the abdomen and for pelvic fracture stabilization. “We are thrilled at the ever-expanding indication range for the AAJT-S and are happy to announce this new clearance by the FDA,” said President and CEO of Compression Works Scott Dodson. “Pelvic fractures that result from automobile accidents, crushing injuries and falls represent a serious health issue and even mortality for accident victims due to their potential to rupture the underlying blood vessels in this area,” said Dodson.
“The U.S. Department of Transportation reports 150,000 pelvic fractures per year. Of those that die, up to 40% are as a result of an underlying hemorrhage due to the disruption in the pelvis. The AAJT-S device can stabilize the broken structure so the accident victim can be safely transported to definitive care for an awaiting surgical team. If there is suspected pelvic bleeding, the AAJT-S can also be used to stop the blood flow to the damaged area,” stated Chief Medical Officer John Croushorn, MD.
The AAJT-S from Compression Works has five distinct uses. The device can be used in the axilla and groin to stop junctional hemorrhage, and is the only junctional tourniquet cleared for use on the abdomen for pelvic bleeding and bilateral lower leg injuries. The AAJT-S can also be used as an adjunct to Zone 3 REBOA as proven in multiple peer-reviewed clinical studies. With the additional FDA clearance for pelvic fractures, the AAJT-S offers more multi-use capabilities for critical areas of the body to help save lives.