New Products and Industry News March

Company gains FDA clearance for dressings

     Derma Sciences Inc (Princeton, NJ) announced that its first BIOGUARD™ Barrier Dressings received US Food and Drug Administration (FDA) clearance for marketing and distribution. The dressing offers surgeons, wound care clinicians, infection control experts, and primary care doctors a new weapon against the transmission of virulent bacteria as methicillin-resistant Staphylococcus aureus (MRSA). The gauze-based line of dressings incorporates Quick-Med Technologies Inc’s (Boca Raton, FL) patented NIMBUS® cationic biocide technology, licensed by Derma Sciences in 2007. This represents the first FDA clearance of a product with the NIMBUS technology. Surgical site infections, as well recent changes in reimbursement practices, are serious concerns; prevention has become a significant objective for hospitals.

     For more information, visit www.dermasciences.com.

Negative pressure wound therapy system is light- weight, multi-functional

     Smith & Nephew’s Advanced Wound Management division (St. Petersburg, FL) announced the US launch of its new Renasys EZ ™ Negative Pressure Wound Therapy (NPWT). The system enables clinicians to treat surgical, traumatic, or chronic wounds according to the individual needs of the patient and the characteristics of the particular wound. At only 7.4 lb, the system can be used with both foam and gauze wound interfaces.

     Features and functions include quick-click connectors that help reduce the risk of error, multiple safety alarms, and a patient lock-out feature that alerts clinicians to changes in pressure status or pump functions. In addition, the system’s battery runs for up to 40 hours and charges in 3 hours. The IV pole and bed mounts reduce the system’s footprint at the patient’s bedside.

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

Total contact cast system simplifies application process

     MedEfficiency (Wheat Ridge, CO) recently introduced the MedE-Kast™ Ultra Total Contact Cast System, a simplified version of the MedE-Kast Total Contact Cast System and incorporates pre-cut splints to reduce the time required to roll a MedE-Kast. The pre-cut splints also make learning proper application easier for those new to total contact casting.

     Time required to apply the new cast system varies per clinician but studies suggest that with experience, it can be applied in ¼ less time than a MedE-Kast. This includes about 5 minutes of preparation time, 6 minutes to roll the cast, and 15 minutes of dry time to allow full weight-bearing in less than 30 minutes.

     For more information, visit www.MedEfficiency.com.

Patient-positioning pads created exclusively for hyperbaric oxygen chambers

     Sechrist Industries (Anaheim, CA) recently introduced the hyperbaric industry’s first patient-positioning pads developed specifically for use in hyperbaric oxygen chambers. The Sechrist HBO2 Patient Comfort Positioning Pads™ are available in three multifunctional configurations: wedge, lumbar support, and lateral support. These configurations provide maximum flexibility in achieving optimum patient comfort during treatment. The compact pads are flame- and moisture-retardant and feature the conductivity required for use in high-oxygen concentration environments.

     The pads are constructed from many of the same materials that have made the Sechrist OmniPressure™ Hyperbaric Chamber Mattress so well received with today’s pressure ulcer patients. The underlying structure of the pads is high-density foam covered in specialized fabric.The fabric cover of the pads is also conductive, antimicrobial, self-deodorizing, and easily cleaned using certified disinfectants.

     For more information, visit www.SechristUSA.com or call (800) SECHRIST.

Company engineers skin substitute with potent anti-infective function

     Stratatech Corp (Madison, WI) has genetically modified its StrataGraft® living human skin substitute to actively fight costly bacterial infections that routinely develop at the sites of burns and ulcers. Bacterial infection is a primary cause of skin graft rejection and can significantly increase the hospital costs of burn and other skin injuries. The company’s skin substitute enables the immediate topical delivery of a potent anti-infective that actively inhibits bacterial growth and promotes re-growth of the patient’s own skin cells.

     The genetically engineered skin substitute, ExpressGraft™, was generated using a non-viral vector. The company believes this is the first time a virus-free approach has been used to genetically modify a living cell-based tissue substitute. The enhanced tissue possesses a full-thickness structure and barrier function similar to that of native human skin.

     An in vivo model of an infected third-degree burn showed that the modified tissue reduced the growth of Acinetobacter baumannii, a pathogenic, multi-drug-resistant bacterium, by 100-fold compared to unmodified tissue. The unmodified tissue contained a bacterial level that exceeded the criteria for clinical infection.

     For more information, visit www.stratatechcorp.com.

Hemostatic dressing patch now available

     HemCon Medical Technologies Inc’s (Portland, OR) flexible hemostatic dressing HemCon® Patch is now available for clinical settings. The dressing can be used for external, temporary control of bleeding during interventional and diagnostic cardiac catheterization, interventional radiology, electrophysiology, and dialysis access procedures. The patch delivers a flexible hemostatic solution where rapid arterial hemostasis is critically important to ensure quality care and safety. It quickly stops bleeding, minimizes risk of artery damage, and frees up medical personnel. One of the only hemostatic products to obtain US Food and Drug Administration antibacterial barrier approval, the patch provides a barrier against a wide spectrum of micro-organisms, including methicillin-resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE), and Acinetobacter baumannii.

     For more information, visit www.hemcon.com.

Non-profit corporation champion for beneficiaries

     The Continuum of Care Coalition (C-3), a non-profit corporation, is a Medicare and Medicaid Beneficiary champion. C-3 has added the goal of deconsolidation of wound care from Consolidated Billing/Prospective Payment Programs to its agenda. The effort was started by American Medical Technologies (Irvine, Calif) in 2004 and has the potential to reduce national healthcare costs by more than $2.2 billion annually and improve the quality of care for Medicare and Medicaid beneficiaries. The C-3 goal is to remove active wound care products from the “standardized” payment made for “usual and normal” services. By allowing separate reimbursement of wound care, early intervention can begin and more positive outcomes achieved sooner.

     For more information, visit www.deconsolidatenow.org or call (609) 249-7944.

Companies partner for patient support

     InnovationRx (Newton, MA) recently partnered with Advanced BioHealing Inc (La Jolla, CA) to conduct a pilot program providing support for patients receiving Dermagraft® treatment, a human-derived dermal substitute approved by the US Food and Drug Administration for the treatment of diabetic foot ulcers. The pilot program, to be launched in Dallas, TX and tested in other US cities, is intended to assist patients and healthcare providers in addressing various issues that negatively affect patient compliance during their treatment for diabetic foot ulcers. This is the first program of its kind for patients receiving advanced treatment for diabetic foot ulcers and represents the benefits of adherence services to pharmaceutical, medical device companies, health plans, and pharmacies.

     For more information, visit www.innovationrx.com or www.advancedbiohealing.com.