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swatsurgeon · 06-04-2013, 13:00

Device to Stop Critical Bleeding in the Field Clears FDA
May 29, 2013
The US Food and Drug Administration (FDA) has granted 510(k) marketing clearance for the iTClamp hemorrhage control system from iTraumaCare of San Antonio, Texas.

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 temporary pool of blood under pressure, which forms a stable clot that mitigates further blood loss until the wound can be surgically repaired, the company explains.

The device requires only minimal training and is compact, measuring less than 2 by 2 inches and weighing less than 3 ounces. "No comparable product exists in the point-of-injury space, solving an unmet medical need," the company says.

An animated video that demonstrates how the system works is available on YouTube.
https://www.youtube.com/watch?v=iVO-QRTGM7U

"With this regulatory milestone achieved, we look forward to putting the iTClamp in the hands of health care professionals in the United States and improving patient care," iTraumaCare's Chief Executive Officer and founder Dennis Filips, MD, said in a statement.

The iTClamp was licensed for sale in Canada in late 2012 and received its CE Mark for sale in Europe in March 2013. It will be available to medical professionals in the United States within 30 to 45 days, the company said.

My 2 cents: great, close the skin and let the blood dissect into different planes and the bleeding source is not addressed so the patient continues to bleed just not all over the floor or on you......How is this device a good thing? In my book, it does not accomplish one tenet of hemorrhage control: must stop at source with manual pressure, i.e., hands, tourniquet, hemostatic dressing, etc. Just closing skin does NOTHING. I have seen this many times when someone closes a laceration somewhere on the body then we get to deal with a large hematoma and blood dissected everywhere in the tissues all the while the patient is STILL HEMORRHAGING!!
Thank you FDA for giving a new toy to those that can't figure out basic hemorrhage control and giving them another way to make the patient's life more fragile.

ss

06-04-2013, 13:00	#1
swatsurgeon Guerrilla Chief Join Date: Jul 2004 Location: Phoenix, AZ Posts: 880	A New Hemorrhage Control Device Device to Stop Critical Bleeding in the Field Clears FDA May 29, 2013 The US Food and Drug Administration (FDA) has granted 510(k) marketing clearance for the iTClamp hemorrhage control system from iTraumaCare of San Antonio, Texas. 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 temporary pool of blood under pressure, which forms a stable clot that mitigates further blood loss until the wound can be surgically repaired, the company explains. The device requires only minimal training and is compact, measuring less than 2 by 2 inches and weighing less than 3 ounces. "No comparable product exists in the point-of-injury space, solving an unmet medical need," the company says. An animated video that demonstrates how the system works is available on YouTube. https://www.youtube.com/watch?v=iVO-QRTGM7U "With this regulatory milestone achieved, we look forward to putting the iTClamp in the hands of health care professionals in the United States and improving patient care," iTraumaCare's Chief Executive Officer and founder Dennis Filips, MD, said in a statement. The iTClamp was licensed for sale in Canada in late 2012 and received its CE Mark for sale in Europe in March 2013. It will be available to medical professionals in the United States within 30 to 45 days, the company said. My 2 cents: great, close the skin and let the blood dissect into different planes and the bleeding source is not addressed so the patient continues to bleed just not all over the floor or on you......How is this device a good thing? In my book, it does not accomplish one tenet of hemorrhage control: must stop at source with manual pressure, i.e., hands, tourniquet, hemostatic dressing, etc. Just closing skin does NOTHING. I have seen this many times when someone closes a laceration somewhere on the body then we get to deal with a large hematoma and blood dissected everywhere in the tissues all the while the patient is STILL HEMORRHAGING!! Thank you FDA for giving a new toy to those that can't figure out basic hemorrhage control and giving them another way to make the patient's life more fragile. ss __________________ 'Revel in action, translate perceptions into instant judgements, and these into actions that are irrevocable, monumentous and dreadful - all this with lightning speed, in conditions of great stress and in an environment of high tension:what is expected of "us" is the impossible, yet we deliver just that. (adapted from: Sherwin B. Nuland, MD, surgeon and author: The Wisdom of the Body, 1997 ) Education is the anti-ignorance we all need to better treat our patients. ss, 2008. The blade is so sharp that the incision is perfect. They don't realize they've been cut until they're out of the fight: A Surgeon Warrior. I use a knife to defend life and to save it. ss (aka traumadoc)
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