SILVER SPRING, Md. – The XSTAT P15, an advanced hemorrhage control device for narrow-entrance wounds, recently received 510(k) clearance as part of joint efforts by Naval Medical Research Command (NMRC) in partnership with a medical device company, RevMedx.

This device uses advanced technology in a smaller version of an existing combat casualty wound care device, the XSTAT P30, designed to treat life-threatening, bleeding wounds in deployed and combat environments.

Warfighters can use the XSTAT P15 applicator to insert a pouch containing miniature sponges into restricted wound sites, such as those caused by gunshots or shrapnel. As the sponges expand, they exert constant pressure onto the wound, minimizing bleeding without the use of manual compression, lessening the risk of complications and eliminating the need for a tourniquet. Application requires no training, reducing the burden on the warfighter. The pouch that the minisponges are contained in allows them to be easily removed during surgery.

Naval Medical Research Command (NMRC) in partnership with medical device company, RevMedx, developed the XSTAT P15, an advanced hemostatic device designed to control severe bleeding in narrow entrance wounds such as those caused by gunshots or shrapnel. This device uses miniature sponges that expand rapidly to exert pressure onto the wound site and can be easily removed during surgery. NMRC, headquarters of Navy Medicine Research & Development, is engaged in a broad spectrum of activity from basic science in the laboratory to field studies in austere and remote areas of the world to investigations in operational environments. In support of Navy, Marine Corps and joint U.S. warfighter health, readiness and lethality, researchers study infectious diseases, biological warfare detection and defense, combat casualty care, environmental health concerns, aerospace and undersea medicine, operational mission support and epidemiology. (U.S. Navy photo by Aleece Williams/Released)

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Naval Medical Research Command (NMRC) in partnership with medical device company, RevMedx, developed the XSTAT P15 an advanced hemostatic device designed to control hemorrhaging. This device is supplied in two easy to use pieces, the plunger and barrel. The barrel houses a pouch of miniature sponges that will rapidly expand to fill the wound site and control hemorrhaging. This device requires no training to be applied effectively and efficiently in emergent situations. Navy Medicine Research & Development, is engaged in a broad spectrum of activity from basic science in the laboratory to field studies in austere and remote areas of the world to investigations in operational environments. In support of Navy, Marine Corps and joint U.S. warfighter health, readiness and lethality, researchers study infectious diseases, biological warfare detection and defense, combat casualty care, environmental health concerns, aerospace and undersea medicine, operational mission support and epidemiology. (U.S. Navy photo by Sidney Hinds/Released)

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Naval Medical Research Command (NMRC) in partnership with medical device company, RevMedx developed the XSTAT P15, an advanced hemostatic device designed to control severe bleeding in narrow entrance wounds such as those caused by gunshots or shrapnel. This device uses miniature sponges that expand rapidly to exert pressure onto the wound site and can be easily removed during surgery. NMRC, headquarters of Navy Medicine Research & Development, is engaged in a broad spectrum of activity from basic science in the laboratory to field studies in austere and remote areas of the world to investigations in operational environments. In support of Navy, Marine Corps and joint U.S. warfighter health, readiness and lethality, researchers study infectious diseases, biological warfare detection and defense, combat casualty care, environmental health concerns, aerospace and undersea medicine, operational mission support and epidemiology. (U.S. Navy photo by Aleece Williams/Released)

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Naval Medical Research Command (NMRC) in partnership with medical device company, RevMedx developed the XSTAT P15, an advanced hemostatic device designed to control hemorrhaging. This device is supplied in two easy to use pieces, the plunger and barrel. The barrel houses a pouch of miniature sponges that will rapidly expand to fill the wound site and control hemorrhaging. This device requires no training to be applied effectively and efficiently in emergent situations. Navy Medicine Research & Development, is engaged in a broad spectrum of activity from basic science in the laboratory to field studies in austere and remote areas of the world to investigations in operational environments. In support of Navy, Marine Corps and joint U.S. warfighter health, readiness and lethality, researchers study infectious diseases, biological warfare detection and defense, combat casualty care, environmental health concerns, aerospace and undersea medicine, operational mission support and epidemiology. (U.S. Navy photo by Aleece Williams/Released)

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“Previously there were makeshift remedies to try to deal with these types of wounds with varying levels of effectiveness. This represents the first FDA approved method, which has also resolved some of the issues inherent in those makeshift remedies,” said Lt. Cmdr. John Casachahua, a product manager for NMRC Naval Advanced Medical Development. “Partnerships like this allow NMRC to create an efficient, focused and agile front that can adapt to the changing needs of military medicine and enhance survivability of our military force in contested environments.”

510(k) premarket clearance allows for marketing and distribution of the XSTAT P15 in the U.S., after confirmation that the device is safe and effective. 510(k) clearance requires submitters to compare their device to one that is already legally marketed and prove that it is “substantially equivalent” (SE).

The XSTAT P15 is intended to help lessen the risk of hemorrhage wounds, which are the cause of approximately 20% of combat wounds across all services.

NMRC, headquarters of Navy Medicine Research & Development, is engaged in a broad spectrum of activity from basic science in the laboratory to field studies in austere and remote areas of the world to investigations in operational environments. In support of Navy, Marine Corps and joint U.S. warfighter health, readiness and lethality, researchers study infectious diseases, biological warfare detection and defense, combat casualty care, environmental health concerns, aerospace and undersea medicine, operational mission support and epidemiology.