Careful fluid management of major burns directly improves the survival rates of patients, but fluid management in these cases is a notoriously difficult process. Not only large volumes of resuscitative fluids are needed to manage these patients, but various pathophysiological changes take place that influence the rate of infusion over time. To help with the process, Arcos Medical of Houston, Texas won the go ahead from the FDA to bring to market its Burn Navigator system, a tool for managing fluid resuscitation in seriously injured patients. It was developed in association with U.S. Army Medical Research Acquisition Activity, the U.S. Army Institute of Surgical Research and the University of Texas Medical Branch, and has already been used successfully for a few years with hundreds of patients.
The Burn Navigator calculates proper fluid delivery by comparing previous hours’ levels to the urine produced by the patient. The company is currently testing a flight-ready version of the device and hopes to have it available in September of this year.
Suzanne Schwartz, MD, MBA, Director of Emergency Preparedness/Operations and Medical Countermeasures, FDA, announced the 510(k) clearance at the American Burn Association 45th annual meeting last week, saying, “This technology is the first of its kind algorithm based decision assist system for use in managing fluid resuscitation of the severely injured burn patient. We consider this a milestone, but even more than that, a peek into what the future has in store for burn trauma management.”
Product page: Burn Navigator…
Press release: Arcos, Inc. Receives FDA 510(k) for Burn Navigator™