GENEVA, Ill., Nov. 30, 2021 /PRNewswire-PRWeb/ -- Argentum
Medical, a medical device leader and pioneer of silver- plated
nylon technology, today announced the U.S. Food and Drug
Administration (FDA) granted the company a Breakthrough Device
designation for its Silverlon® Wound Contact, Burn Contact
Dressings.
Silverlon dressings are critical in helping to prevent infection
in wound or burn victims. Silverlon antimicrobial silver-plated
dressings have 50 to 100 times more metallic silver ions than other
silver- impregnated dressings.
The FDA's Breakthrough Device Program creates a pathway for
patients and health care providers to have more timely access to
innovative medical devices by expediting their development,
assessment, and review while preserving the statutory standards for
premarket approval.
"This important FDA Breakthrough Designation has been 20 years
in the making and is the ultimate validation for Silverlon," said
Raul Brizuela, president and CEO of
Argentum Medical. "Receiving this designation will expedite our
efforts to bring Silverlon to patients with radiation dermatitis
and cutaneous radiation injury."
The indications for use of Silverlon® Wound Contact, Burn
Contact Dressings granted designation by the FDA are for
application up to 7 days for radiation dermatitis and cutaneous
radiation injury through dry desquamation or not requiring skin
grafting.
"The FDA Breakthrough Devices program was created to help bring
effective treatment of life- threatening or irreversibly
debilitating conditions to market sooner – and Silverlon is a
perfect candidate for this program due to its clinical importance
and impact," adds Brizuela.
Key to determining Silverlon's efficacy on radiological injuries
after emergency was a $10.1M
development contract awarded to Argentum Medical by the Biomedical
Advanced Research and Development Authority (BARDA), part of the
HHS Office of the Assistant Secretary for Preparedness and Response
(ASPR). The contract with BARDA advanced development of radiation
exposure wound technology and allowed researchers to explore how
Silverlon can treat low-grade and acute skin radiation
injuries.
In fact, BARDA has already purchased Silverlon, so it's
available through the Strategic National Stockpile.
Brizuela points out that Silverlon technology is more effective
than its competitors because of its ability to stretch and adhere
across a bodily area, resulting in more exposure to and longer
duration on a wounded area. This was an attribute that became
advantageous in the wars in Iraq
and Afghanistan when personnel
couldn't restock medical equipment quickly enough. Rather than
relying on wound dressings that needed to be changed every few
hours, Silverlon could be used for much longer stretches of time,
reducing the need for rapid resupply.
In addition, the RAND Corporation — a nonprofit, nonpartisan
research organization — found in its 2020
RAND Report that silver-nylon dressing is a useful strategy
to help prevent infection and provide prolonged care of burn
injuries — a leading cause of military battlefield fatalities. The
report, "The Effect of Blast-Related Burn Injuries from Prolonged
Field Care to Rehabilitation and Resilience," (available for
download here) was sponsored by the U.S. Army Medical Research and
Development Command and the Department of Defense Blast Injury
Research Coordinating Office. The report highlights evidence about
the antimicrobial properties of silver nylon dressings as critical
to infection prevention after burn or blast injuries.
RAND researchers conducted an independent, comprehensive
literature review and synthesis of the evidence surrounding
blast-related burn injuries. Findings and recommendations presented
in the report are intended to raise awareness about the current
state of the science in treating burn injuries. According to the
report, burns are one of the most difficult types of injury to
treat:
- Infection control and prevention are critical to burn care,
especially because research shows that pathogens to which service
members are exposed in current combat operations are increasingly
resistant to antibiotics.
- Research shows that appropriate bandaging to avoid infection is
critical; silver-nylon dressing has been found to be uniquely
portable and easy to use and has key antimicrobial properties.
- The report also includes a 2018 study that found "compared with
topical antimicrobial agents, silver-nylon dressing had lower
infection rates …"
- Newer silver-plated dressings are ideal for prolonged field
care. They can be left in place for seven days without being
changed and can be rewetted to be used again.
The 2020 RAND report's summary
recommendations – based on results of the literature review and
synthesis of the evidence – point to silver nylon dressing as a
potential standard of care.
Multiple, peer-reviewed, published clinical studies also have
shown the significant benefits of Silverlon in a wide variety of
surgical, wound and burn-care settings. These studies suggest
Silverlon dressings can be an important element in wound care and
that control of wound bacteria within the dressing may help reduce
the risk of infection.
Silverlon is recognized by the Federal Drug Administration for
use on first- and second-degree burns, partial and full thickness
wounds and most recently, sulfur-mustard burns.
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 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 companies continue to explore new
applications and markets for SILVERLON® technology in keeping with
their corporate mission to improve clinical outcomes.
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Media Contact
Elaina Boudreau, BELA
Communications, (913) 660-0548, eboudreau@belapr.com
SOURCE Argentum Medical