Top 10 News Items of '09
Derma Sciences, Inc. (Princeton, NJ), a specialty medical device/pharmaceutical company specializing in advanced wound care, recently announced that the US Food and Drug Administration (FDA) has issued its Guidance Document to support the classification of the company's BIOGUARDâ„¢ barrier gauze wound dressings as Class II medical devices. This novel wound dressing received its initial market clearance on February 25, 2009, via the FDA's de novo review process, a special clearance program for medical devices that are found to be "not substantially equivalent" to any predicate device. The newly issued guidance pertains to a wound dressing with permanently bound cationic biocide polyDADMAC, one of the molecular entities covered in nine Quick-Med US patents/patents pending and in 24 foreign counterparts.
Visit www.dermasciences.com for more information.
Leading medical journal, Podiatry Today, published its annual list of "Top Innovations in Podiatric Care" in the August 2009 issue. Listed at number 5 on the top 10 list is TheraGauze™, the wound dressing manufactured by Soluble Systems LLC (Newport, Va). The article highlights the company's proprietary Skin Moisture Rebalancing Technology (SMRT), which enables the dressing to "read" a wound and donate or absorb moisture as needed to enhance healing outcomes of difficult chronic wounds. The dressing is a sterile proprietary polymer dressing that regulates moisture differentially across the wound site. When used as directed, the dressing remains moist and active for up to 7 days— reducing the frequency of dressing changes. The SMRT dressing will not macerate tissue or stick to the wound, and leaves no residue. The dressing has received the prestigious "Seal of Approval" from the American Podiatric Medical Association, and is clinically proven to surpass even growth factor treatment for the closure of diabetic foot ulcers.
Visit www.solublesystems.com for more information.
Prospera Technologies (Fort Worth, Tex) announced that Swedish researchers directly compared the use of high- and low-pressures for negative pressure wound therapy (NPWT) in a pig model. Clinicians are pointing out the biological benefits of lower, intermittent, and variable pressures such as reduced patient pain and increased granulation tissue formation. For example, Christian Torbrand, MD of Lund University (Sweden) presented "Biological Effects of Negative Pressure Wound Therapy at Low Levels of Negative Pressure—Intermittent and Variable Negative Pressure Wound Therapy." The study represents several firsts in NPWT research: the effects of lower negative pressure on regional blood flow, wound contraction, and fluid removal. Biological effects in response to intermittent and variable pressure were delineated for the first time in detail. Using laser Doppler in a pig wound model, Torbrand and colleagues examined effects at pressures ranging from as low as −10 mm Hg to −175 mm Hg. In variable NPWT, two alternating pressure levels are used, but negative pressure is always maintained without a drop to 0 mm Hg. The study showed blood flow changed gradually with increasing levels of negative pressure, reaching 100% of maximum effect at approximately −75 mm Hg. These study results challenge the conventional way of thinking about NPWT and the use of higher negative pressures.
Visit www.prospera-npwt.com for more information.
Industry News
FDA Issues Guidance for Derma Sciences' Exclusive Wound Dressing with pDADMAC
Derma Sciences, Inc. (Princeton, NJ), a specialty medical device/pharmaceutical company specializing in advanced wound care, recently announced that the US Food and Drug Administration (FDA) has issued its Guidance Document to support the classification of the company's BIOGUARDâ„¢ barrier gauze wound dressings as Class II medical devices. This novel wound dressing received its initial market clearance on February 25, 2009, via the FDA's de novo review process, a special clearance program for medical devices that are found to be "not substantially equivalent" to any predicate device. The newly issued guidance pertains to a wound dressing with permanently bound cationic biocide polyDADMAC, one of the molecular entities covered in nine Quick-Med US patents/patents pending and in 24 foreign counterparts.
Visit www.dermasciences.com for more information.
TheraGauzeâ„¢ Named One of the Year's Top Podiatric Innovations
Leading medical journal, Podiatry Today, published its annual list of "Top Innovations in Podiatric Care" in the August 2009 issue. Listed at number 5 on the top 10 list is TheraGauze™, the wound dressing manufactured by Soluble Systems LLC (Newport, Va). The article highlights the company's proprietary Skin Moisture Rebalancing Technology (SMRT), which enables the dressing to "read" a wound and donate or absorb moisture as needed to enhance healing outcomes of difficult chronic wounds. The dressing is a sterile proprietary polymer dressing that regulates moisture differentially across the wound site. When used as directed, the dressing remains moist and active for up to 7 days— reducing the frequency of dressing changes. The SMRT dressing will not macerate tissue or stick to the wound, and leaves no residue. The dressing has received the prestigious "Seal of Approval" from the American Podiatric Medical Association, and is clinically proven to surpass even growth factor treatment for the closure of diabetic foot ulcers.
Visit www.solublesystems.com for more information.
Prospera Technologies' Research Challenges Conventional Thinking
Prospera Technologies (Fort Worth, Tex) announced that Swedish researchers directly compared the use of high- and low-pressures for negative pressure wound therapy (NPWT) in a pig model. Clinicians are pointing out the biological benefits of lower, intermittent, and variable pressures such as reduced patient pain and increased granulation tissue formation. For example, Christian Torbrand, MD of Lund University (Sweden) presented "Biological Effects of Negative Pressure Wound Therapy at Low Levels of Negative Pressure—Intermittent and Variable Negative Pressure Wound Therapy." The study represents several firsts in NPWT research: the effects of lower negative pressure on regional blood flow, wound contraction, and fluid removal. Biological effects in response to intermittent and variable pressure were delineated for the first time in detail. Using laser Doppler in a pig wound model, Torbrand and colleagues examined effects at pressures ranging from as low as −10 mm Hg to −175 mm Hg. In variable NPWT, two alternating pressure levels are used, but negative pressure is always maintained without a drop to 0 mm Hg. The study showed blood flow changed gradually with increasing levels of negative pressure, reaching 100% of maximum effect at approximately −75 mm Hg. These study results challenge the conventional way of thinking about NPWT and the use of higher negative pressures.
Visit www.prospera-npwt.com for more information.
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