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swatsurgeon
06-04-2013, 14:00
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

miclo18d
06-05-2013, 17:29
Thanks Doc.

I read most of your post then watched the vid; before I saw your take on it, I was thinking....WTF?

On an 18D perspective (and I know others will have different opinions on this) I was taught that you can bleed out about 50% of your blood volume into the interstitial cavities, etc with a closed femoral artery wound. I don't think their "video man" has to worry about the real world, but in my world the only thing that stops a bleeder like that is a tourniquet.

Loss of blood on the battlefield can't be replaced and remember all you new 18Ds getting ready to go into harms way. That MEDEVAC that they say is 30 minutes out is actually an hour out and it will take the cherry pilot 10 attempts to land because of brownout which will be another 30 minutes. Blood carries "O's to the toes" not lactated ringers. STOP THE BLEEDING period or your going to have a mess on your hands!

swatsurgeon
06-05-2013, 20:00
Thanks Doc.

I read most of your post then watched the vid; before I saw your take on it, I was thinking....WTF?

On an 18D perspective (and I know others will have different opinions on this) I was taught that you can bleed out about 50% of your blood volume into the interstitial cavities, etc with a closed femoral artery wound. I don't think their "video man" has to worry about the real world, but in my world the only thing that stops a bleeder like that is a tourniquet.

Loss of blood on the battlefield can't be replaced and remember all you new 18Ds getting ready to go into harms way. That MEDEVAC that they say is 30 minutes out is actually an hour out and it will take the cherry pilot 10 attempts to land because of brownout which will be another 30 minutes. Blood carries "O's to the toes" not lactated ringers. STOP THE BLEEDING period or your going to have a mess on your hands!

Well said and words of wisdom......
ss

Sdiver
06-05-2013, 21:23
Thanks Doc.

I read most of your post then watched the vid; before I saw your take on it, I was thinking....WTF?

On an 18D perspective (and I know others will have different opinions on this) I was taught that you can bleed out about 50% of your blood volume into the interstitial cavities, etc with a closed femoral artery wound. I don't think their "video man" has to worry about the real world, but in my world the only thing that stops a bleeder like that is a tourniquet.

Loss of blood on the battlefield can't be replaced and remember all you new 18Ds getting ready to go into harms way. That MEDEVAC that they say is 30 minutes out is actually an hour out and it will take the cherry pilot 10 attempts to land because of brownout which will be another 30 minutes. Blood carries "O's to the toes" not lactated ringers. STOP THE BLEEDING period or your going to have a mess on your hands!

"O's to the toes" .... I like that one.

I've always used .... EMS rule #1: Air goes in and out; Blood goes round and round .... Any deviation from the two, needs fixin' ASAP !!!!

Doc SS ... thanks for posting this. I had/have the same reaction as you do after reading this. Such a waste of time, money and resources researching this, and it isn't going to do any good to help in saving people. It'll only make it worse.

The Reaper
06-05-2013, 22:14
How does that saying go?

All bleeding stops. Eventually.

TR