FDA Grants New 510k Clearance for LifeFlow® for Use with Blood

Sep 17, 2020 |

– New treatment option for patients with hemorrhagic shock or life-threatening bleeding –

Durham, NC, – September 17, 2020 — 410 Medical, a medical device company developing innovative products for resuscitation of critically ill patients, is pleased to announce the U.S. Food & Drug Administration (FDA) has granted 510(k) clearance for a new product in the LifeFlow family. Clinicians can use the new LifeFlow device for rapid delivery of blood and blood components, in addition to crystalloid and colloid resuscitative fluids.

“Severe hemorrhage is a leading cause of potentially preventable death from trauma and other causes of life-threatening bleeding,” commented Dr. Mark Piehl, Co-founder and Chief Medical Officer of 410 Medical. “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.”

Worldwide almost 2 million people die of hemorrhagic shock each year.  Most of these deaths are caused by trauma, though many others result from conditions such as maternal hemorrhage and gastrointestinal bleeding.   Now EMS and hospital providers who are presented with patients with trauma and hemorrhage have a new option to help with resuscitation.

Galen Robertson, COO for 410 Medical, remarked, “Building on our existing technology, the new LifeFlow will provide similar benefits of fast and efficient delivery in an easy-to-use system with the added ability to deliver blood products. We want to thank all the doctors, nurses, and paramedics who continue to provide critical feedback and input that fuel our engineering and product development team.”

A full market release is anticipated by early 2021.

Learn more about LifeFlow PLUS Blood & Fluid Infuser.

 

About 410 Medical, Inc.

Founded in 2013, 410 Medical is developing and distributing innovative products that enable frontline medical providers to improve care for critically ill patients. 410 Medical’s first product family, the LifeFlow infusion system, is designed for patients in urgent need of rapid volume resuscitation. For more information visit www.410medical.com.

References:

Pyle H. et al. Prehospital Fluid Management in Hemorrhagic Shock. JEMS online 2019.
Cannon JW. Hemorrhagic Shock. NEJM 2018;378(4):370-379.

 

Media Contact:
Carla Hoffman
choffman@410medical.com

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