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news.Derma Sciences has said that the FDA has given 510K clearance to the company’s second dressing in the Medihoney line. This dressing is indicated for use on wounds with light to moderate exudate, and based on its hydrocolloidal properties forms a gel when it comes into contact with wound fluid to assist in promoting a moist environment conducive to healing.
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The new dressings, both in adhesive and non-adhesive versions, have been shown to lower the pH level of wounds. When wound pH is lowered, it has been shown that protease modulation and increased oxygen diffusion take place, both beneficial to hard-to-heal wounds. Additionally, the dressings due to their high levels of glucose and other sugars, have been shown to promote a strong osmotic effect. This osmotic effect, drawing fluid from surrounding tissues, helps to constantly bathe wounds in lymph fluid, which assists in the removal of necrotic tissue, slough, and debris from the wound bed.
The first Medihoney dressing from Derma Sciences, cleared for use by the FDA in July 2007, is in an alginate base and is indicated for wounds with moderate to heavy levels of exudate. The new dressings are expected to be launched in the first quarter of 2008.
Edward Quilty, CEO of Derma Sciences, said: “This is another important milestone in the launch of our Medihoney dressings. Ultimately, we intend to offer clinicians a complete line of dressings based on the patented honey-based wound dressing technologies we have licensed from our partner, Comvita New Zealand.”