410 Medical announced that it received FDA 510(k) clearance for its LifeFlow device in the rapid delivery of blood and blood components.
Durham, N.C.-based 410 Medical’s LifeFlow device is a rapid infuser designed to deliver one liter of crystalloid fluid through a 20-gauge IV catheter in five minutes for front-line treatment of patients needing urgent fluid delivery. The company launched the LifeFlow device on a limited basis in November 2016.
Clinicians now have the ability to use LifeFlow for the rapid delivery of blood and blood components in addition to its capabilities with crystalloid and colloid resuscitative fluids. On the back of the latest clearance, the company expects to execute a full-market launch by early 2021, according to a news release.
“Severe hemorrhage is a leading cause of potentially preventable death from trauma and other causes of life-threatening bleeding,” 410 Medical co-founder & chief medical officer Dr. Mark Piehl said in the release. “Current methods of treating hemorrhage are often too slow or complex to work effectively when minutes matter. LifeFlow provides a simple and efficient option to front line providers caring for critically ill patients who need blood products delivered quickly.”