A new therapeutic method, which can be used for the treatment of pressure ulcers, diabetic ulcers, post-surgical wounds and first and second degree burns, recently received FDA clearance.
February 26, 2010
EnzySurge Ltd. (EnzySurge) received clearance from the U.S. Food and Drug Administration (FDA) in December to market its new SilverStream™ solution for prescription use. The FDA also cleared DermaSept, an Over-the-Counter version of the SilverStream product.
EnzySurge is the developer of the DermaStream® product line, a line of woundcare devices that allows for the continuous streaming of fresh therapeutic solutions, such as SilverStream, over the wound bed. The treatment provides constant removal of foreign material, exudate, micro-organisms and debris while creating negative pressure over the wound.
SilverStream may be either applied directly onto the wound or by the disposable DermaStream® device. According to Dr. Noa Hadar and Prof. Amihay Freeman who led the development, SilverStream is a hypertonic solution that contains very low concentration of preservative silver ions.
“SilverStream has demonstrated remarkable capabilities by in-vitro testing inhibiting the growth of drug-resistant clinical bacterial strains, yeast and fungi upon contact in-vitro,” says Freeman.
SilverStream is intended for use under the supervision of a healthcare professional for management and moisturizing of wounds such as stage I-IV pressure ulcers, stasis ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, cuts abrasions and minor skin irritations. DermaSept is intended for the management and moisturizing of minor cuts, minor burns, abrasions and irritated areas.
The treatment of chronic wounds (such as diabetic, pressure and venous ulcers) is expensive, laborious and requires ongoing application and monitoring by a skilled caregiver. The global market for chronic wound products amounted $3.2 billion in 2008 and is expected to grow to $4.1 billion by 2011.
Source: Medgadget, http://biomed-blogs.com/biomed2010/242