January New Products and Industry News

Antimicrobial foam dressing introduced
  Mölnlycke Health Care US LLC (Norcross, GA) recently introduced their newest product, Mepilex® Border Ag antimicrobial bordered foam dressing with Safetac® technology. The dressing represents the next generation of antimicrobial wound dressings that offer an all-in-one dressing that effectively absorbs and retains exudate and maintains a moist wound environment. The new dressing has powerful silver performance that inactivates wound-related pathogens within 30 minutes and sustains antimicrobial effect for up to 7 days.   The Safetac® layer seals the wound edges, which allows exudate to pass into the absorbent core and minimizes the risk of maceration. The dressing features a multilayered absorbent foam pad that consists of compressed foam with silver and a fiber layer for maximum fluid retention. This combination absorbs, spreads, and retains exudate while allowing the silver to be released. The dressing is ideal for medium to high exuding wounds that require a moist environment, exudate management, gentle fixation, and antimicrobial action, including leg and foot ulcers, pressure ulcers, superficial and partial-thickness burns, traumatic wounds, and surgical wounds.

For more information, visit www.molnlycke.us.

Relaunched products address skin damage prevention
  3M Skin & Wound Care (St. Paul, MN) has relaunched the 3M™ Cavilon™ Professional Skin Care line, a full range of products to help prevent skin damage from moisture, friction, and adhesive trauma. Following extensive research and surveys of caregivers and clinicians, the Cavilon brand has been updated with new packaging to help easily identify the right product for a specific need. Widely known for its Cavilon No Sting Barrier Film, the company also plans to introduce new Cavilon products starting later this year with Cavilon Antifungal Cream. This new product relieves redness, irritation, scaling, itching, discomfort, and burning due to athlete’s foot, jock itch, and ringworm. It also offers barrier properties to protect against moisture and an easy-to-spread formula to soothe affected areas. In 2011, the company will be adding enhanced product formulations, sizes, and new patient-friendly delivery systems to the product line, which includes a full range of comforting and convenient products such as an extra dry skin cream, hand moisturizer, a no-rinse skin cleanser, and lotion for incontinence care. For more information, visit www.3M.com/healthcare.

Silicone dressing protects and conforms
  Systagenix (London, UK) recently launched Adaptic Touch™ Non-Adhering Silicone Dressing, a new primary silicone wound contact layer comprised of a cellulose acetate mesh coated with a soft tack silicone. This dressing addresses the needs of both patients and healthcare professionals — it protects the wound, provides maximum conformability, stays in place, is easy to remove, and minimizes tissue damage and adherence to the secondary dressing. Efficient manufacturing processes make silicone contact dressings more accessible to clinicians and patients around the world, helping relieve pressured healthcare budgets without compromising clinical performance.

For more information, visit www.systagenix.com.

Collaborative promotion of skin prep should deliver cost savings
  3M (St. Paul, MN) and Medline Industries Inc (Mundelein, IL) signed an agreement to promote 3M™ DuraPrep™ Surgical Solution Patient Preoperative Skin Preparation. This collaboration is expected to provide hospitals and healthcare providers with a high-quality product and significant cost savings. The skin-prepping solution meets the guidelines of the Centers for Disease Control (CDC) and Association of periOperative Registered Nurses (AORN). The solution eliminates the need for a time-consuming scrub and paint application by combining two proven, broad-spectrum antimicrobial agents: alcohol for quicker kill and drying and iodine povacrylex for persistence in a water-insoluble film. The solution is effective in a single painted coat, providing ease and quickness of use in a self-contained applicator. Earlier this year, a budget impact analysis (BIA) of three surgical preparation solutions demonstrated that this solution already provided the most overall cost savings compared to both povidone-iodine scrub paint and ChloraPrep® Patient Preoperative Skin Preparation (ChloraPrep). The results of the BIA, which was funded by 3M, were presented in March at the Society for Health Epidemiology of America (SHEA) Fifth Decennial International Conference on Healthcare-Associated Infections.

For more information, visit www.3m.com or www.medline.com.

Debridement device receives CE mark
  ArthroCare Corp (Austin, TX) announced that its WoundWand™ Debridement Device is Conformité Européenne (CE) marked and available for distribution in Europe. Using ArthroCare’s patented Coblation® technology, the wand enables necrotic tissue to be removed from a wound in a precise and controlled manner.

  The wand is intended for wound debridement in acute and chronic wounds and wound cleansing by removal of necrotic tissue. Nearly 2.7 million people in Europe suffer from leg and foot ulcers with costs exceeding 12 billion Euros annually. The wand currently is not available for sale in the United States.

For more information, visit www.arthocare.com.

New wound care website launched
  Following the highly successful global launch of the new corporate identity, Systagenix (London, UK) unveiled its newly designed website (www.systagenix.com). The site was designed to be easy to browse and will provide a resource for wound care practitioners around the world searching for clinical evidence, best practice, product specifications, or information relating to new innovations regarding wound care, including the developments in the area of point-of-care testing. Visitors to the site will have access to clinical and scientific evidence supporting the company’s product portfolio. The site revolves around the company’s Let’s Heal™ system, which comprises four main categories: Let’s Test™ — to provide wound care diagnostic tools; Let’s Protect™ — to protect from infection using products such as Silvercel® Non-Adherent, the antimicrobial designed to not stick to wounds; Let’s Promote™ — to promote wound healing in ways that standard dressings can't achieve; and Let’s Comfort™ — to offer a comfortable and effective healing environment for all types of wounds.

For more information, visit www.systagenix.com.

Burn wound cream developed
  Life Science Company, Melcare Biomedical (Mt. Cotton, Australia) shipped its first export order of locally developed Derma Care cream dressing to South Korea.  

 The company has developed a range of specialist products for skin care, wound care, and dry eye disease. Earlier this year, the company launched a range of animal wound care products destined for international markets. The products have been formulated to make use of the varying properties of medical honey (also known as Australian Manuka honey) produced from Australian Leptospermum shrubs. The cream will hopefully help the millions of people disabled and disfigured by burns every year. The skin’s natural protective layer (the acid mantel) is lost or severely disrupted after a serious burn. The cream has been designed to have similar properties to the acid mantel to help support and protect the skin’s natural barrier to bacteria and allergens.

For more information, visit www.melcare.com.

Technology company introduces dermal skin graft
  MMI-USA (Memphis, TN), a subsidiary of Memometal Technologies S.A., a global orthopaedic manufacturer headquartered in Bruz, France, has launched MemoDerm™ Acellular Dermal Matrix, a terminally sterilized, single-application onlay graft used to promote healing of diabetic foot ulcers and other soft-tissue repairs. The graft will be a technology platform for a future family of products.

  The graft demonstrates the company’s commitment to improve the standard of care and expand the science in the extremity orthopedic market. Open wounds affect 15% to 24% of the approximately 20 million Americans with diabetes and can be a challenge to medical professionals. These ulcers precede 85% of the 80,000 lower limb amputations that occur each year. Many of these patients are at increased risk for limb-threatening infection; having a sterile treatment such as the new graft offers an advantage in lowering infection risk.

For more information, visit www.mmi-usa.com.

New procedure codes facilitate choice of clinically appropriate products
  Organogenesis Inc (Canton, MA) announced Apligraf®, the only product with FDA approval for the treatment of both diabetic foot ulcers and venous leg ulcers, will have two new procedure codes assigned by the Centers for Medicare and Medicaid Services (CMS) beginning in January 2011. The new codes will enable physicians to receive appropriate reimbursement for each application of the product in accordance with its FDA labeling criteria, which includes weekly assessment and up to five applications as needed. The new Healthcare Common Procedure Coding System (HCPCS) codes will include site preparation and debridement and 0-day global billing period. The new codes are: G0440 (Application of tissue cultured allogeneic skin substitute or dermal substitute; for use on lower limb, includes the site preparation and debridement if performed; first 25 sq cm or less); and G0441 (Application of tissue cultured allogeneic skin substitute or dermal substitute; for use on lower limb, includes the site preparation and debridement if performed; each additional 25 sq cm).

  The new codes were created to address inconsistencies in valuing the use of bioengineered skin substitutes for the treatment of chronic wounds. Some application codes allowed for separate billing of site preparation and debridement; whereas, the product’s application codes already included site preparation and debridement. Under the new codes, physicians will be reimbursed fairly for each application of the product as directed by the company’s FDA labeling, based on pivotal clinical trials.

For more information, visit www.apligraf.com.

Continence association launches council for quality performance standards 
  The National Association For Continence (NAFC, Charleston, SC) is heading a newly formed council with the objective of establishing national, independent quality standards for disposable adult absorbent products. The standards are relevant to Medicaid waiver recipients cared for in their private homes rather than as residents of state-funded nursing homes. This council represents a diversity of patient and caregiver advocacy organizations, industry, clinical nursing expertise, and state health agency perspectives. The goals of this initiative are to: 1) create a single, national set of standards for adult absorbent products for all Americans allowing elimination in redundancy of effort among 50 states, 2) clarify and communicate absorbent product characteristics needed by frail, elderly users who are incontinent so as to simplify and expedite the agency procurement process of sourcing products, 3) optimize value in absorbent product purchases by all states, 4) improve the quality of care of program participants and lower risks of adverse events such as skin breakdown from use of substandard products, and 5) establish a benchmark for continuous quality improvement over time. No industry funding is being provided in connection with this initiative. The NAFC hopes the council can complete this undertaking in the coming year.

  Currently, the acquisition of supplies for managing incontinence of Medicaid waiver participants is being targeted to help cut or curb expenses for many states whose budgets are exceeding revenue because of escalating healthcare costs. Medicaid waivers are considered a means of saving the expense of costly nursing home placement by relying on family caregivers in a private home setting. However, some states have no quality standards to specify what types of supplies for incontinence are allowable. Few, if any, states have recognized, evidence-based quality standards. Some products are sourced from manufacturers whose quality control is questionable and subject to variation.

  Nancy Muller, PhD, executive director of the NAFC and OWM columnist, will serve as chair of the council. Members of the council consist of individuals responsible for managing the Medicaid waiver programs for their respective states in various regions of the country, specifically California, Texas, Minnesota, and South Carolina and technical support representatives from all of the leading nonwoven manufacturers in the US, including Kimberly Clark, SCA, First Quality, and Attends.

For more information, visit https://cts.vresp.com/c/?TheNationalAssociati/1cd00971cb/1a3a751dc8/3aa4ef2b24.

FDA approval granted to manufacture collagenase ointment
  DPT Laboratories Ltd (San Antonio, TX), a pharmaceutical contract development and manufacturing organization, received FDA approval to manufacture commercial supplies of a leading sterile ointment for wound care at its Center of Excellence for Sterile & Specialty Products in Lakewood, NJ. Such approval underscores the company’s commitment to serve the healthcare community and improve patient health and quality of life. DPT and Healthpoint (Fort Worth, TX) have had a long and mutually beneficial relationship over the years; DPT is Healthpoint’s preferred manufacturing partner on a variety of products. The recent FDA approval of DPT’s Lakewood facility to produce the ointment allows Healthpoint to immediately double its production capacity; thereby, helping ensure continuous, uninterrupted supply for this important therapeutic agent.

For more information, visit www.dptlabs.com.

Diabetic foot ulcer device module submitted for FDA approval
  Sanuwave Health Inc (Alpharetta, GA) submitted the first module of its dermaPACE™ device for the treatment of diabetic foot ulcers to the US Food and Drug Administration (FDA) for Premarket Approval (PMA). The company received FDA permission through the acceptance of its shell application in August 2010 to file the PMA for the device in a series of three sections or modules. The first module included preclinical data and results of prior clinical testing. The company planned to submit the second module containing a quality manufacturing system review by the end of 2010. The company anticipates filing the third module containing data from the recently completed the pivotal Phase III clinical trial of the device to treat diabetic foot ulcers proposed product labeling and a summary of safety and effectiveness in the first quarter of 2011.

For more information, visit www.sanuwave.com.

Companies join forces to distribute wound care products
  Ahmedabad-based Lincoln Pharmaceuticals Ltd (LPL, Gujarat, India) teamed with US-based Human Biosciences Inc (HBI, Gaithersburg, MD) for exclusive marketing and distribution of two of HBI’s wound care management products in India — Medifil™ and Skin Temp™ — that enjoy a 22% market share in their category. Both products, due to faster healing properties, are useful in repairing wounds during plastic and burns surgery, general surgery, orthopedic surgery, and gynecological surgery and are particularly beneficial for diabetic amputations. Medifil is available in an absorbable collagen-based granule and Skin Temp in an absorbable collagen-based patch. The company has the option of setting up a manufacturing unit in the future to increase production of these products. The mission of Lincoln Pharmaceuticals is to provide customers with high-quality healthcare products at an affordable price. The company is planning to establish a manufacturing unit in India to increase production and expand its reach so more people can enjoy the benefits of these products.

For more information, visit https://ausib.org/Lincoln-Pharma-ties-up-with-US-based-Human-Biosciences-Inc_1415_AUSIB-News.html.