News

Hemorrhage control system gets expanded approval


 

iTClamp® Hemorrhage

Control System

The US Food and Drug Administration has expanded the indication for the iTClamp® Hemorrhage Control System.

It is now approved to provide temporary control of severe bleeding of the neck. The product was already approved for use on the extremities, axilla, inguinal areas, and the scalp.

The iTClamp is a temporary wound closure device designed to control severe bleeding in seconds.

It seals the edges of a wound closed to create a temporary pool of blood under pressure. This forms a stable clot that mitigates further blood

loss until the wound can be surgically repaired.

Each iTClamp measures less than 2 by 2 inches and weighs less than 3 ounces. It requires only minimal training and gross motor skills to use, according to iTraumaCare, the company that makes the product.

“Addressing difficult-to-control hemorrhage in the neck has been a consistent problem with few solutions,” said Dennis Filips, MD, founder and chief medical officer of iTraumaCare.

“This expanded indication for the iTClamp will allow first responders, medical professionals, and tactical and battlefield medics to use the device in even more meaningful ways to improve patient care.”

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