Le Lézard
Classified in: Health
Subject: FDA

Argentum Medical Announces 510(k) Clearance of Silverlon Burn and Wound Care Products for Vapor Sulfur Mustard Indication


GENEVA, Ill., July 29, 2019 /PRNewswire-PRWeb/ -- Argentum Medical announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for Vapor Sulfur Mustard indication for its Silverlon Burn and Wound Care products. This is the first medical product cleared in the U.S. for use on these injuries.

As a pioneer in silver technology, Argentum Medical partnered with the Biomedical Advanced Research and Development Authority (BARDA), which funded the necessary studies to show that Silverlon was appropriate for use on certain injuries caused by sulfur mustard exposure. Used as a chemical weapon, sulfur mustard is a blistering agent that causes severe, delayed burns and has been used in warfare to cause delayed casualties. BARDA is a component of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

"What we have accomplished is an amazing example of what can happen when government, the scientific community and industry collaborate for the common good," states Raul Brizuela, CEO of Argentum Medical. "As the only approved medical countermeasure for sulfur mustard, we are proud to be able to help save as many lives as possible in a national emergency."

Silverlon has received FDA clearances for multiple indications since 2003.

Silverlon's Military Heritage
Developed for combat injuries, Silverlon antimicrobial technology is used throughout the U.S. military in the management of burn and blast injuries, Silverlon products contain 50 to 100 times more metallic silver ions than other silver-impregnated dressings and have been shown to be highly effective in hostile and austere military environments.

Silverlon is incorporated into numerous deployed Medical Tactical Combat Casualty Care kits and is also supplied in bulk to Combat and Support Hospitals and Tactical Forward Surgical Teams. The wound dressing is also included in burn care protocols in the Joint Theater Trauma System Clinical Practice Guideline.

Silverlon burn products and protocols are extensively used by the US Army and by US Air Force Critical Care Air Transport (CCAT) teams and are taught at the US Air Force School of Aerospace Medicine Critical Care Air Transport Basic Course.

Beyond the military, Silverlon dressings are used today by surgeons and other healthcare professionals around the world on surgical wounds, in negative pressure wound therapy, on chronic wounds, burns, skin grafts, and IV and catheter-related wounds.

Argentum Medical continues to explore new applications and markets for its Silverlon® technology in keeping with its corporate mission to improve clinical outcomes. For more about Silverlon, visit http://www.silverlon.com.

The development of Silverlon for use on sulfur mustard injuries has been funded in whole or in part with funds from BARDA under Contract No. HHSO100201300019C.

About Silverlon
Silverlon® wound dressings have a permanently plated metallic surface, which provides the antimicrobial benefits of silver in the dressing without staining the skin and without increasing bioburden. Silverlon was originally developed for the U.S. military, where it is still extensively used for management of burn and blast injuries. Silverlon dressings are used today by surgeons and other healthcare professionals around the world on surgical wounds, in negative pressure wound therapy, on chronic wounds, burns, skin grafts, and IV and catheter-related wounds. For more, visit http://www.silverlon.com.

About Argentum Medical
Argentum Medical pioneered the use of silver-plated nylon. Specializing in the development of innovative products made from silver-plated nylon, the company continues to explore new applications and markets for its Silverlon® technology in keeping with its corporate mission to improve clinical outcomes.

SOURCE Argentum Medical


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