New Products and Industry News September

Product helps improve catheter application

     Ethicon Inc (Somerville, NJ) announced that the Biopatch® Protective Disk with chlorhexidine gluconate (CHG) will include new design elements and updated packaging to make it easier for surgeons, nurses, and other healthcare providers to apply the product correctly around catheters to reduce the risk of catheter-related bloodstream infections (CRBSIs). The disk is placed directly on the skin at the point of catheter insertion and provides 7 days of continuous active antisepsis.

     The design and packaging for the disk include easy-to-follow instructions and clearly marked “up” arrows for correct skin orientation. This new design is intended to provide clear and immediate guidance on the application of the disk with each use. In a clinical study, the use of the disk was associated with a 76% reduction in CRBSI. The disk is the only product of its kind with an FDA-cleared indication to reduce CRBSI.

     For more information, visit www.ethicon.com.

System assists surgeons achieve primary fascial closure

     Kinetic Concepts Inc (San Antonio, TX) launched the ABThera™ open abdomen negative pressure therapy system, the latest addition to its negative pressure technology platform (NPTP). According to company estimates, approximately 250,000 open abdomen procedures are performed annually in the US and EU.

     The system addresses patient quality of life by helping surgeons manage and treat the open abdomen through primary fascial closure. The benefits of the new system include the active removal of fluid and the reduction of edema, providing medial tension that helps minimize fascial retraction and loss of domain, assistance in isolating viscera and the abdominal compartment from the external environment, separation between the abdominal wall and viscera, and removal of infectious and inflammatory materials from the abdomen. The system can be used adjunctively with other KCI products. In most serious cases, surgeons can use the LifeCell Strattice™ Reconstructive Tissue Matrix or AlloDerm® Regenerative Tissue Matrix, products from the company’s regenerative medicine division, as a bridging material to help achieve wound closure following the application of ABThera.

     For more information, visit www.kci1.com.

Company launches wound care product line in US

     Smith & Nephew Inc’s Advanced Wound Management division (St. Petersburg, FL) announced the US launch of Acticoat™ Flex 3 and Acticoat™ Flex 7 to expand the Acticoat portfolio. The products have been designed to support physicians dealing with wounds and injuries at high risk of infection. Utilizing the Silcryst® nanocrystalline silver technology of Acticoat, the products provide enhanced conformability on awkward anatomical areas such as the face and hands and breakthrough stretch properties to improve patient comfort during wear. Created to work in hard-to-dress areas, the products were recently cleared for market use by the US Food and Drug Administration; they were cleared for use by Health Canada in late 2008. Combining the flexibility of the polyester mesh substrate with the proven effectiveness of Acticoat’s nanocrystalline silver technology is a significant development for the brand.

     For more information, visit www.smith-nephew.com.

Powder accelerates foot wound healing

     Foot complications such as open wounds and ulcers can be difficult for podiatrists to treat. A new wound dressing powder that acts very much like a layer of skin appears to speed healing time and reduce the amount of pain a patient suffering from a serious foot ulcer would normally experience. This includes open sores on the feet as a result of disease, diabetes, or skin cancer. The study results will be released at the American Podiatric Medical Association’s (APMA) 97th Annual Scientific Meeting in Toronto this year and will highlight the powder’s ability to rapidly heal foot wounds and advance the treatment patients currently receive.

     This wound powder is especially promising for the nearly 24 million Americans diagnosed with diabetes. Diabetic foot ulcers are the leading cause of nontraumatic, lower-limb amputations in the US. In a recent APMA survey, 18% of people with diabetes reported they have experienced a foot sore that would not heal. This powder’s successful treatment of difficult foot wounds could potentially lead to a reduction in amputation rates. The study focused on atypical wounds with irregular shapes and causes. The wounds were treated with the powder dressing once a week for 4 to 8 weeks. The study ultimately showed that the powder dressing provided a painless, efficient, and protective treatment that assisted in closing the wound. The powder also helped in preparing the wound for further interventions that are sometimes needed — eg, skin grafts or the use of sutures.

     For more information, visit www.apma.org.

Dual purpose gauze dressing controls bleeding and protects burns

     SAM Medical Products (Portland, Ore) recently launched CELOX Trauma Gauze™. The dual-purpose hemostatic gauze is used to control traumatic bleeding and to cool and protect first- and second-degree burns. The product was designed to effectively meet the needs of the armed forces and emergency services personnel who often work in the field with limited medical supplies. As the newest addition to the CELOX line of temporary traumatic wound treatments, the gauze is composed entirely of CELOX’s chitosan chemistry. Unlike some hemostatic gauze products, the new product is not impregnated or coated with a hemostatic agent, but instead consists of 100% of the chitosan-derived gauze material, which is used in the treatment of the wound. Within 30 seconds, the gauze controls bleeding by reacting with red blood cells to form a robust clot. Once saturated with water or saline, this same product transforms into a gel-like material that is able to cool and protect burns. The gauze can absorb almost two cups of water or one cup of blood; in addition, it can be applied and is safe for patient use.

     For more information, visit www.sammedical.com.

Dressing campaign launched along with best practice statement

     ConvaTec (Skillman, NJ) launched a new campaign and best-practice statement supporting Versiva® XC® gelling foam dressing. Supported by extensive in vivo and in vitro data, the new campaign shows how healthcare professionals can expect better outcomes when using the foam dressing. The only cover dressing to contain the company’s proprietary Hydrofiber® Technology, the dressing transforms wounds through its powerful gelling action. This action enables dressings to lock in exudate and its harmful components and to contour closely to the wound bed in response to changing wound conditions.

     Outlining proposed minimum standards for wound care, the best practice statement, Optimizing the Use of Versiva® XC® Gelling Foam Dressing, was developed by a panel of wound care experts in collaboration with Wounds UK, with financial support from ConvaTec. Selected excerpts were distributed as a supplement to the August 2009 issues of Ostomy Wound Management and Today’s Wound Clinic. The expert recommendations are intended to provide appropriate guidance in an accessible format to help healthcare professionals manage patients. When developing the best practice statement, the authors conducted an extensive literature review and a retrospective evaluation of 50 patients with wounds of various types that were managed using the dressing. In multicenter clinical studies, the dressing demonstrated clinical efficacy within the protocols of care for managing venous leg ulcers and pressure ulcers. In the study, which comprised patients with venous leg ulcers, a significant reduction (P <0.001) was noted in mean wound area (50% in 4 weeks from baseline). In a retrospective analysis using data from two previous clinical trials, healing rates at 4 weeks were found to be powerful predictors of complete wound healing at 12 weeks.

     For more information, visit www.convatec.com.

Polymer dressing named one of the year’s top podiatric innovations

     Podiatry Today published its annual list of “Top Innovations in Podiatric Care” in its August 2009 issue. At number five is TheraGauze (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.

     For more information, visit www.solublesystems.com.

Silver dressing receives FDA approval

     Exciton Technologies Inc (Edmonton, Alberta) received approval from the US Food and Drug Administration to market exSALT™ SD7 Wound Dressing, a product incorporating the company’s patented platform coating technology that utilizes silver oxysalts as the active ingredient. The dressing targets the advanced wound care market in preventing infection during the treatment of burn and chronic wounds, such as diabetic foot ulcers and pressure ulcers. By adjusting the dose of silver, expanding the number of product configurations, reducing costs, and being amenable to more applications such as consumer products, catheters, and orthopedic devices, the company can target a greater portion of the overall wound care market.

     For more information, visit www.excitontech.com.

Validity of negative pressure wound therapy patents confirmed

     Kinetic Concepts Inc ([KCI] San Antonio, Tex) announced that the US Patent and Trademark Office (USPTO) issued Office actions confirming the validity of three separate patents licensed to KCI by Wake Forest University (Winston Salem, NC) Health Sciences in re-examination proceedings. The patents associated with this decision include US Patent Numbers 5,636,643 (the ‘643 Patent), 5,645,081 (the ‘081 Patent), and 7,216,651 (the ‘651 Patent), which all relate to KCI’s negative pressure wound therapy technologies. The USPTO has provided public notice of its intent to issue certificates of re-examination affirming the validity of key claims in the ‘643 Patent and the ‘081 Patent. The USPTO also issued a formal Office action confirming the validity of all claims in the ‘651 Patent.

     For more information, visit www.KCI1.com.