Geneva, Ill. November 15, 2022— Argentum Medical, a medical device leader and pioneer of silver-plated dressing technology, announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Radiation Dermatitis (RD) and Cutaneous Radiation Injury (CRI) through dry desquamation for its Silverlon® Burn and Wound Care products.
Silverlon® is the first medical device to be cleared in the U.S. for management of Cutaneous Radiation Injury through dry desquamation.
“This historic achievement is the culmination of more than 20 years of effort, thousands of hours of work and significant investment by our government. We are proud to provide an FDA cleared product for the management of these injuries and further assist with disaster preparedness for our country,” states Raul Brizuela, CEO of Argentum Medical.
The key to determining the effectiveness of Silverlon for management of radiological injuries was an $11.6 million development contract awarded to Argentum Medical by the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Administration for Strategic Preparedness and Response (ASPR).
Peter Antinozzi, Ph.D., Argentum Medical’s Project Manager of the BARDA funded project, credits the resolute efforts of the interdisciplinary project team of industry, government, and academic experts for this achievement. “In the past three years, our highly productive private-public partnership between Argentum Medical and BARDA has yielded two critical FDA clearances to support a joint goal of disaster preparedness against chemical and radiological threats. The experimental approaches to support these clearances were innovative and state-of-the art and involved the development of novel methods and models.”
In 2019, Silverlon® received the first FDA clearance for mustard-induced vesicant injuries, which established Silverlon® as a safe treatment for chemical warfare injuries such as vapor sulfur mustard burns. Now, in 2022, Silverlon® has received the first FDA medical device clearance for both radiation dermatitis and cutaneous radiation injuries. This is truly a unique clearance, a dual-role clearance, which has immediate medical treatment benefits to manage radiation dermatitis, a common side-effect of radiation therapy for cancer treatment, and establishes Silverlon® as a safe and effective product to manage cutaneous radiation injuries resulting from accidental or intentional radiation incidents.
“Silverlon technology is highly effective relative to other products on the market because of its ability to stretch and conform across a bodily area, resulting in more exposure to and longer duration on a wounded area,” adds Raul Brizuela. “Rather than rely on a wound dressing that needs to be changed every few hours, Silverlon can be used for much longer periods of time, reducing the need for rapid resupply. The clinical trial data (NCT04238728, clinicaltrials.gov) that supports this novel clearance demonstrated the feasibility, patient compliance, and safety of Silverlon® use to manage radiation-induced injuries such as radiation dermatitis.
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 for the management of burn and blast injuries. Silverlon products contain 50 to 100 times more metallic silver ions than 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 mustard-induced vesicant injuries, radiation dermatitis and cutaneous radiation injuries has been funded in whole or in part with federal funds from BARDA under contract numbers HHSO100201300019C and HHSO1002018000022C.
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 information, visit 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.
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