Argentum Medical, a Geneva, Ill.-based medical device company, announced Tuesday that the U.S. Food and Drug Administration (FDA) had granted its Silverlon Wound Contact, Burn Contact Dressings a Breakthrough Device designation.
The FDA’s Breakthrough Device Program creates a pathway for patients and healthcare providers to have timely access to new medical devices by expediting their development, assessment, and review while preserving 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.”
Silverlon dressings have antimicrobial silver-plated dressings with 50 to 100 times more metallic silver ions than other silver-impregnated dressings. The indications for the use of the dressings granted by the FDA are for application up to seven days for radiation dermatitis and cutaneous radiation injury through dry desquamation or not requiring skin grafting.
Argentum Medical was awarded a $10.1 million contract by the Biomedical Advanced Research and Development Authority (BARDA) to further develop the dressings’ radiation exposure wound technology and allowed researchers to study Silverlon’s effectiveness in treating low-grade and acute skin radiation injuries.
“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,” Brizuela said.