Robert Glatter, MD, Emergency Medicine, 11:55AM Jul 21, 2013
In late May of 2013, the FDA granted 510(k) marketing clearance for the iTClamp hemorrhage control system from iTraumaCare of San Antonio, Texas.
Based on information from the company, the device is designed to control severe bleeding from a penetrating injury in seconds by sealing closed the edges of a wound to create a hematoma which forms a stable clot that reduces further blood loss until the wound can be surgically repaired. The design was actually inspired from the design and mechanics of a hair clip.
The device requires only minimal training and is compact, measuring less than 2 by 2 inches and weighing less than 3 ounces. This is a unique product that functions as a point-of-injury device to control severe bleeding.
The product may certainly have a role for first responders in the field, as well as for patients with exsanguinating hemorrhage who present to the emergency department as part of a resuscitative effort.
Broader emergent use at such venues as sporting events, similar to the concept of an AED by non-medical providers, may potentially be an additional role for such a product. The use of universal precautions (gown,gloves,mask) would have to be part of any such kit.
Thus far, the product has already been licensed for sale in Canada and Europe.
Here is a YouTube video that demonstrates the iTClamp.
Robert Glatter, MD