New "injectable" hemostatic agent cleared for civilian use by FDA (Read 10375 times)

HiCarry

A "new" product.....

Quote
A novel wound dressing now used to control severe bleeding on the battlefield will be available to civilian first responders treating trauma patients, the US Food and Drug Administration (FDA) has announced.

The agency today cleared XSTAT-30 (RevMedX) wound dressing for patients at high risk for immediate, life-threatening, and severe hemorrhagic shock and noncompressible junctional wounds when they can't be treated at an emergency-care facility within minutes. XSTAT-30 is not indicated for certain parts of the chest, abdomen, pelvis, or tissue above the collarbone, according to an FDA news release.

The wound dressing product consists of a syringe-style applicator holding 92 compressed cellulose sponges with an absorbent coating. The sponges expand with blood and fluid to fill the wound cavity, temporarily blocking blood flow for up to 4 hours. Each applicator's worth of sponges can absorb about one pint of blood, although the number of sponges needed to control bleeding will vary by the size and depth of the wound.

http://www.revmedx.com/#!xstat-dressing/c2500

mauidog

An unarmed man can only flee from evil, and evil is not overcome by fleeing from it.   -- Jeff Cooper

HiCarry

Re: New "injectable" hemostatic agent cleared for civilian use by FDA
« Reply #2 on: December 08, 2015, 11:17:51 AM »
Before the recent FDA clearance the product was only available to the military. It is now available to the civilian market....

whynow?

Re: New "injectable" hemostatic agent cleared for civilian use by FDA
« Reply #3 on: June 10, 2016, 08:45:29 PM »
Until Xstat become mainstream for the public and costs go down, does anyone sell Celox retail here?   In process of putting together a group med kit and would like to get some Celox pads.
I see that Amazon sells but would like to get locally if available and reasonable priced.

whynow?

Re: New "injectable" hemostatic agent cleared for civilian use by FDA
« Reply #4 on: June 12, 2016, 09:02:49 PM »
Well couldn't find links for Celox in Hawaii so ended up going through Amazon for Celox Z and the applicator with granules and some quick clot sponges.
Celox tend to have longer shelf life than QClot.

London808

"Mr. Roberts is a bit of a fanatic, he has previously sued HPD about gun registration issues." : Major Richard Robinson 2016

London808

Re: New "injectable" hemostatic agent cleared for civilian use by FDA
« Reply #6 on: June 15, 2016, 05:48:21 PM »
Also

XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents.
 
XSTAT 30 is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk for immediate life-threatening bleeding from, hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non- compressible junctional wounds, and when definitive care at an emergency care facility cannot be achieved within minutes
 
XSTAT 30 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space; the sacral space above the inguinal ligament; or tissues above the clavicle.
"Mr. Roberts is a bit of a fanatic, he has previously sued HPD about gun registration issues." : Major Richard Robinson 2016

whynow?

Re: New "injectable" hemostatic agent cleared for civilian use by FDA
« Reply #7 on: June 15, 2016, 08:44:20 PM »
Celox and applicator/

https://www.amazon.com/CELOX-Clotting-Granule-Applicator-Plunger/dp/B0123DT4RQ/ref=sr_1_4?ie=UTF8&qid=1466048737&sr=8-4&keywords=celox
I ordered that  item along with some pads/sponge since they claim it doesn't produce heat like some hemostatic agents.