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domingo, 1 de octubre de 2017

Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS". Cleared to Stop Gun and Knife Wounds in Arms and Legs

Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS"


Dr. Ramon Reyes, MD


XSTAT FDA Cleared to Stop Gun and Knife Wounds in Arms and Legs by medGadged 




RevMedX just announced that the FDA has cleared its XSTAT 12 and XSTAT 30 devices for stopping severe bleeding from knife and gun-shot wounds in the arms or legs. The XSTAT devices are essentially large syringes that can be used to quickly push dozens of tablet-sized highly absorbent pieces of foam into a wound. Once the foam tablets are inside the wound, they quickly expand, blocking the blood from escaping and delivering pressure onto the wound from within. Each tablet contains a radiopaque marker so it can be easily found using X-ray fluoroscopy during surgery.
Previously, the XSTAT devices have been FDA approved for use in civilian and battlefield situations, but only to treat junctional wounds around the groin and shoulders. The new indication will help more wounds to be quickly treated, hopefully helping to prevent arm and leg loss and even death.
Here’s a quick demo of the XSTAT being used on a leg:

WILSONVILLE, Ore., May 20, 2016 /Ireach PR Newswire/
For Immediate Release

RevMedx™ Announces First Field Use of  XSTAT®


XSTAT® is a first-in-kind hemostatic device for the treatment of gunshot and shrapnel wounds. XSTAT works by injecting a group of small, rapidly-expanding sponges into a wound cavity using a syringe-like applicator. Each sponge contains an x-ray detectable marker. In the wound, the XSTAT sponges expand and swell to fill the wound cavity within 20 seconds of contact with blood. This creates a temporary barrier to blood flow and provides hemostatic pressure. 

“When a product is developed for use in the battlefield, it is generally intended to work in a worst­ case scenario where advanced care might not be immediately available,” said William Maisel, M.D., M.P.H., acting Director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “It is exciting to see this technology transition to help civilian first responders control some severe, life-­threatening bleeding while on the trauma scene.” 

Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS"



Indications for Use:

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.


RevMedx, Inc. today announced that the XSTAT hemostatic device has been successfully deployed on a patient in a field setting.  The use of XSTAT on a soldier was the first documented clinical use of the product since its release. After failing to staunch severe bleeding in the patient using standard hemostatic technologies, a United States forward surgical team (FST) used XSTAT to achieve almost immediate hemostasis. 
Based on information released from the US Military, a coalition forces soldier was wounded in action with a gunshot wound to the left thigh.  The femoral artery and vein were transected and damage to the femur and soft tissue left a sizable cavity in the leg.  After a self-applied tourniquet stopped the bleeding, the patient was transferred to an FST for evaluation and treatment.  After proximal and distal control of the vessel was achieved, several hours were spent by the team trying to control residual bleeding from the bone and accessory vessels.  Throughout the course of the roughly 7-hour surgery, multiple attempts at using bone wax and cautery on the bleeding sites were unsuccessful and the patient received multiple units of blood and plasma.  Eventually, the FST team opted to use XSTAT and applied a single XSTAT device to the femoral cavity— resulting in nearly immediate hemostasis. The patient was stabilized and eventually transported to a definitive care facility. 
XSTAT is a first-in-kind hemostatic device for the treatment of severe bleeding in the axilla or groin area (known as junctional wounds). XSTAT works by injecting a group of small, rapidly-expanding sponges into a wound cavity using a syringe-like applicator.  In a wound, the sponges rapidly expand and exert hemostatic pressure.  Each sponge contains an x-ray detectable marker to confirm complete surgical removal when definitive surgery is performed. 

"The first-in-human experience with XSTAT is the culmination of tremendous effort on the part of both RevMedx and our military collaborators,” said Andrew Barofsky, president and CEO of RevMedx.  "We are pleased to see XSTAT play a critical role in saving a patient’s life and hope to see significant advancement toward further adoption of XSTAT as a standard of care for severe hemorrhage in pre-hospital settings” said Barofsky.

About RevMedx
Based in Wilsonville, Oregon, RevMedx is a privately held medical device company whose goal is to design, develop, and manufacture innovative medical products that save lives. Our product line includes XSTAT, XGAUZE, AIRWRAP, PARABELT, and TX Series Ratcheting Tourniquets.  Additional information about RevMedx and our products can be found at www.revmedx.com.

Media Contact:
Will Fox
VP Sales & Marketing
Phone: (503) 218-2172

LIFE-SAVING SYRINGE RECEIVES FDA APPROVAL



Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS"

Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS"

Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS"



XSTAT gets the go-ahead for new battlefield tool

XStat, developed by RevMedx, has recently gained FDA approval. The new device functions as a temporary dressing for gunshot and shrapnel wounds, where a tourniquet cannot be used, such as injuries to the groin or armpit.

It has been designed for emergency battlefield situations, where  patients may be some way away from dedicated trauma theatres.  In many cases this is a life and death issue. In a study of soldiers who died between 2001 and 2009 of wounds that weren’t immediately fatal, exsanguinating hemorrhage or bleeding out, was the cause of death in an estimated 80 percent of cases.
The XStat device consists of a syringe-like applicator that contains 92 compressed, cellulose sponges which are coated with an absorbent material. Each tablet-sized sponge measures only 9.8mm in diameter and 4 to 5mm in height. The ultra-absorbent sponges areinjected directly into the wound and rapidly swell to fill the wound cavity, thus stemming blood loss. Designed to remain in place for up to four hours, each XSTAT sponge contains an x-ray detectable marker for speedy removal on hospitalization.
Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS"


Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS"


Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS"


Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS"






FDA APPROVES SYRINGE-LIKE DEVICE FOR PLUGGING GUNSHOT WOUNDS

ORIGINALLY DESIGNED FOR THE MILITARY, THIS INJECTABLE SPONGE PACK COULD CHANGE THE WAY EMTS TREAT GUNSHOT VICTIMS.

The Food and Drug Administration has approved for civilian use a revolutionary device that can stop bleeding from a gunshot wound in less than a minute. On December 7, the agency gave the green light to deploy the XStat 30 to hospitals.
The simple invention is a syringe-like tool that injects tiny sponges into a wound to treat hemorrhaging. Originally developed with troops in Iraq and Afghanistan in mind, the XStat 30 could change the way gunshot victims are treated in the U.S.
The device is designed to plug bleeding from bullet and shrapnel injuries to the groin, armpits, and other areas where applying traditional tourniquets could be difficult.
"When a product is developed for use in the battlefield, it is generally intended to work in a worst-case scenario where advanced care might not be immediately available," said William Maisel of the FDA’s Center for Devices and Radiological Health. "It is exciting to see this technology transition to help civilian first responders control some severe, life-threatening bleeding while on the trauma scene."
The device is the brainchild of a small startup in suburban Portland, Oregon, called RevMedx, which primarily designs products for military personnel and emergency first responders. This past April, RevMedx shipped XStat devices to the military for the first time.
Over the long term, these devices and similar ones could reduce gun deaths in the United States. Data from the United States Army Institute of Surgical Research suggests 30% to 40% of civilian traumatic injury deaths are due to blood loss.
[Photo: XSTAT via RevMedx]

Information related: 




The Hartford Consensus III Compendium, September 2015. PHTLS B-Con Bleeding Control for the Injured







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