US approval for Cheshire woundcare specialist’s products
Cheshire woundcare specialist Advanced Medical Solutions Group has been awarded approval by US authorities for two products.
The Winsford firm said it had received noticed from the FDA (Food and Drug Administration) in the US, of Premarket 510(k) approvals for the group’s surgical silver post operative dressing and for PHMB foam dressing.
These new approvals will allow the group and its distribution partners to offer clinicians advanced woundcare dressings that help prevent and treat infection and accelerate the healing of chronic and high risk surgical wounds, saving time and cost burden to the payors.
It is expected that both of these products will be launched in the US in the fourth quarter of 2018.
The surgical silver post operative dressing is indicated for use in the management of post-operative surgical wounds and consists of two skin-friendly layers of hydrocolloid securing a silver-containing absorbent antibacterial alginate dressing.
It has been shown to be effective against Methicillin-Resistant S. aureus (MRSA) as well as a broad spectrum of microbes including other antibiotic resistant strains.
The PHMB foam dressing is a polyurethane foam impregnated with polyhexamethylene biguanide (PHMB) that is indicated for use in the management of various chronic and post-surgical wounds, including pressure sores, diabetic ulcers, and burns.
The PHMB foam dressing has also been shown to be effective against MRSA and a broad spectrum of microbes.
Advanced Medical Solutions chief executive, Chris Meredith, said: “These most recent approvals strengthen our advanced woundcare portfolio in the US and provide further significant products to support our OEM customers and end users.
“We are particularly pleased to be able to demonstrate the value of our R&D and regulatory capabilities which are a key pillar of our strategy to drive organic growth.”