New Products and Industry News

FDA clears single use negative pressure wound therapy system

  Smith & Nephew plc (Largo, FL) announced FDA clearance of the pocket-sized PICO system, a single-use negative pressure wound therapy (NPWT) system. The system is cleared for use in the hospital and home care settings and expands the use of NPWT from the traditional wound care population to include a wider range of patients undergoing orthopedic surgery, plastic surgery, and general surgical procedures. This FDA clearance follows the recent successful launch of the system in Europe, Canada, and Australia.

  The NPWT system is indicated for chronic, acute, and traumatic wounds; subacute and dehisced wounds; partial-thickness burns; ulcers (such as diabetic or pressure); flaps and grafts; and closed surgical incisions. The system is as easy to apply as a conventional wound dressing, reducing the need for the staff time, intensive training, and administrative paperwork associated with traditional NPWT. The simple application technique can be viewed online via an MS Tag included on the packaging.

  The system’s easy to-use one-button pump, small size, and silent operation provide a discreet, unobtrusive way for the patient to carry on daily life with NPWT. The disposable device’s dressing technology manages fluids, eliminating the need for bulky canisters. The system can be worn on a wound up to 1 week, depending on exudate level. Its gentle silicone wound contact layer helps minimize pain at a dressing change. More affordable than traditional NPWT, the system can reduce therapy costs associated with traditional NPWT. The system is available off-the-shelf, potentially reducing the occurrence of delayed hospital discharges.

  Clinicians and patients can refer to the 24/7 negative pressure wound therapy hotline, (866) 998-NPWT (6798), for more information about the NPWT portfolio of products from the company.

  For more information visit www.possiblewithpico.com or follow the @woundcare Twitter handle for the latest news from the Advanced Wound Management division of Smith & Nephew.

Companies sponsor EB dressing giveaway

  Dystrophic Epidermolysis Bullosa Research Association (DebRA, New York, NY) has partnered with Hollister Wound Care (Libertyville, IL) to give away samples of RESTORE Contact Layer FLEX dressing with TRIACT Technology.

  The dressing offers all the benefits of the original RESTORE Contact Layer dressings — nonadherence for pain-free removal and a moist wound interface in the presence of exudate — on a flexible mesh that allows for greater conformability and comfort.

  For more information and to access the form to receive a sample, visit https://secure.commonground.convio.com/debra/hollisterflexgiveawayvr/.

Clostridium difficile-associated diarrhea treatment has economic advantage

  Data presented at the American Society of Health-System Pharmacists 46th Midyear Clinical Meeting show that the economic value of Optimer Pharmaceuticals, Inc’s (San Diego, CA) DIFICID® (fidaxomicin) tablets to the US health system meets or exceeds the price per day to treat Clostridium difficile-associated diarrhea (CDAD) compared to vancomycin.

  Results showed that when data accounting for the cost and frequency of disease recurrence are factored into an economic equation weighing the value of the tablets against three common regimens of vancomycin, the overall value, which ranged from 95% to 141% of the drug’s wholesale acquisition cost, indicates it is cost saving in many treatment scenarios. The study was sponsored and funded by Optimer Pharmaceuticals.

  For more information, visit www.dificid.com.

HCPCS C-Code awarded for amniotic membrane

  MiMedx Group, Inc (Kennesaw, GA) received a transitional pass-through status C-Code from the Centers for Medicare and Medicaid Services for its EpiFix® Amniotic Membrane Allograft. It has been assigned a pass-through status under Medicare’s outpatient prospective payment system effective January 1, 2012. This code will facilitate reimbursement for the application of the product when used in Medicare patients with chronic wounds and cover grafts used in treating dermal wounds in the hospital operating room or a freestanding surgical suite.

  Visit www.mimedx.com for more information.

Seat cushion helps with pressure ulcer treatment

  EHOB, Inc (Indianapolis, IN) has added the WAFFLE® Extended Care Seat Cushion to its product line for the treatment and prevention of Stage I through Stage IV pressure ulcers and deep tissue injury.

  The product is recommended for patients at home or in a long-term care setting and intended for individuals up to 300 lb. Each cushion features a low-profile design to provide safety and convenience for getting in and out of chairs. Its air-venting holes allow heat and moisture to dissipate for a higher level of comfort.

  For more information, visit www.ehob.com.

Registered dietitians excluded from direct billing for obesity therapy

  In the recent decision memorandum by the Centers for Medicare and Medicaid Services (CMS) regarding Intensive Behavioral Therapy for Obesity (CAG-00423N), the agency determined that potentially life-saving preventive services for obesity could only be furnished by primary care providers in the primary care setting. As a result, the CMS eliminated the most qualified providers, notably registered dietitians (RDs), along with clinical psychologists and other specialists who have been able to produce the best results for patients. The decision prevents this group from directly billing for services and from providing services outside of primary care, and limits access for older patients to qualified professionals that would help manage chronic disease.

  More than 25,000 clinicians responded to a request to urge the CMS to reconsider its decision excluding RDs from direct billing for Obesity Therapy by signing ADA’s petition to President Obama.

Blue foam dressing helps visualize wound exudate

  Spiracur Inc (Sunnyvale, CA) introduced SNaP® BLUE Foam Dressing Kit at the Symposium on Advanced Wound Care (SAWC) Fall 2011 in Las Vegas. The blue foam makes it easier to visualize wound exudate, while minimizing the risk of leaving pieces of foam in the wound upon removal.

  The new foam dressing kit enables the distribution of even levels of negative pressure, promotes granulation tissue formation, enhances macrodeformation of wound edges, and allows for visualization of exudate and excess foam particles.

  For more information visit, www. spiracur.com.

Skin care line to be exclusively distributed

  McKesson Medical-Surgical (Richmond, VA) has become the exclusive distributor of THERA™ Advanced Skin Care therapy.

  The product line includes Foaming Body Cleanser, Antimicrobial Body Cleanser, Moisturizing Body Cleanser, Moisturizing Body Shield, Dimethicone Body Shield, Calazinc Body Shield, Moisturizing Body Cream, and Antifungal Body Powder. These new products are infused with SAFFLEX™, a blend of vitamins and minerals, as well as safflower seed oil, ginger root extract, and lavender ylang fragrance.

  A study shows the cream has been clinically proven to improve epidermal turnover time by 2.1 days.

  For information visit www.theraskincare.com.

Insurance codes for wound dressing awarded

  SteadMed™ Medical (Fort Worth, TX) has been awarded HCPCS codes for its Drawtex® hydroconductive wound dressing by the Centers for Medicare and Medicaid Services (CMS). These codes, A6196-A6199, allow all eight sizes of the wound dressing to be reimbursable by Medicare.

  The company has an exclusive licensing and distribution agreement with Beier Drawtex® Healthcare (Pty) Ltd (South Africa) for the US and Canada and is the sole distributor of the hydroconductive wound dressing in the US.

  For more information, visit www.SteadMed.com.

Ultrasonic debridement and negative-pressure wound therapy product debuted

  PuriCore (Malvern, PA/Stafford, UK) launched Vashe Wound Therapy for Instillation Applications, a solution for adjunctive therapies for wound care including ultrasonic debridement and negative pressure wound therapy.

  The product features a solution of hypochlorous acid, the same naturally occurring chemical used by the human body to defend against invading pathogens. Various pack sizes are available in 125-, 250-, and 500-mL bottles and incorporate a hanger system and septum cap assembly that works in conjunction with a vented infusion set for controlled flow of the wound care solution.

  The therapy is intended for moistening, irrigating, cleaning, and debriding acute and chronic wounds including Stage I through Stage IV pressure ulcers, stasis ulcers, diabetic ulcers, postsurgical wounds, first- and second-degree burns, abrasions, and minor irritations of the skin. The hypochlorous acid acts as a preservative to rapidly kill 99.999% of methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococc, Acinetobacter baumannii, Escherichia coli, and other dangerous pathogens in solution in just 15 seconds in laboratory testing with no known microbial resistance.

  The new solution with preservative passes the USP<51> Antimicrobial Effectiveness Test, demonstrating rapid effective activity in solution against a broad spectrum of gram-positive, gram-negative, and yeast species.

  For more information, visit www.puricore.com.

New product line for advanced wound care launched

  MediPurpose® (Atlanta, GA) announced that inventory for its new MediPlus™ Advanced Wound Care Product is now available for immediate distribution. The advanced wound care product line currently features foams, hydrocolloids, hydrogels, thin films, postsurgical dressings, and nonadherent pads.

  Additionally, the company announced last month that it received US Food and Drug Administration 510(k) clearance for its silver foam wound dressings, which were expected to be available by the end of last this year.

  For more information, visit www.medipurpose.com/mediplus.

Wound care line now available within US government’s healthcare system

  Keraplast Technologies (San Antonio, TX) has been added to Marathon Medical’s (Commerce City, CO) existing Federal Supply Schedule contract, administered by the Department of Veterans Affairs on behalf of the US General Services Administration.

  The arrangement allows the company to expand the availability of its Replicine Functional Keratin wound care products throughout the entire federal healthcare system-- the largest healthcare provider in the US, with more than 1,300 veterans’ health facilities, Department of Defense medical treatment facilities, military hospitals, Native American health service hospitals, and other government agencies.

  For more information, visit www.keraplast.com.

Grant awarded for clinical trial of antimicrobial skin substitute

  Stratatech Corp (Madison, WI) was awarded a $4.6 million grant by the National Institute of Diabetes and Digestive and Kidney Diseases to support the first human clinical trial of ExpressGraft™ antimicrobial skin substitute. The clinical trial will assess the safety and efficacy of the tissue as a treatment for chronic diabetic foot ulcers. This product is the first therapeutic skin substitute to be genetically enhanced to fight infection and accelerate wound healing.

  The skin substitute is a living, cell-based tissue with the physical, chemical, and histological characteristics of human skin. When applied topically to nonhealing ulcers, this tissue provides immediate wound closure and is expected to be gradually replaced by the patient’s own cells during the wound healing process. The tissue’s unique ability to produce a potent immune system protein enables it to actively fight infections that routinely develop at the site of diabetic foot ulcers.

  The antimicrobial skin substitute has been genetically enhanced to actively express elevated levels of cathelicidin, a naturally occurring protein. Data published in the journal Molecular Therapy demonstrated that the company’s genetically enhanced tissue produced 140-fold greater levels of cathelicidin protein in vitro compared to unmodified control tissue. An in vivo model showed that the modified tissue reduced the growth of A. baumannii by more than 100-fold compared to unmodified tissue.

  For more information, visit www.stratatechcorp.com.

Company recognized by founders’ alma mater

  Intellicure (College Station, TX) was among the top 100 companies named to the 2011 Aggie 100, an annual list honoring the fastest-growing companies in the world, owned or operated by Texas A&M University former students. It was recognized as number 37 on the list, with a growth rate of 34.56%.

  David Walker, President and CEO, and Caroline Fife, MD, Chief Medical Officer, both former students of Texas A&M University, founded the company in 2000. The Aggie 100 list may be viewed in its entirety at www.aggie100.com.

  For more information visit www.Intellicure.com.

Group aims to unify voice for wound patients

  The Association for the Advancement of Wound Care (AAWC) (Malvern, PA) is calling for supporters of patient advocacy. To be eligible to belong to this list, a patient, previous wound sufferer, one’s personal lay-caregiver(s), family members, neighbors, or friends must support the organization’s goal to create a unified voice for wound patients.

  Much like a petition to capture supportive names for a cause, anyone who wishes to give back to his/her community by offering his/her name in support of those suffering from wounds is encouraged to join. There is no catch, no fee, and no further action required on the part of an individual after providing his/her name and address.

  This group has been named “Wounds in Need” (WIN), and offers support, networking, education, and information about wound care to the lay-public, wound patients, and their personal caregivers. The group also provides an annual report of association activities that have been undertaken to achieve the goal, all free-of-charge.

  Anyone interested should contact Patient_Advocacy@aawconline.org or call Karen Strauss toll-free at 800-237-7285, extension 113.

  For more information, visit aawconline.org.

Algorithmic approach addresses treatment of fecal incontinence

  A paper published in Touch Gastroenterology addresses the immediate need for a reasoned, stepwise algorithm for treating bowel control disorder (BCD), also known as fecal incontinence (FI). The review evaluates all aspects of the disease state, including some of the newer therapeutic alternatives, and outlines the latest treatment algorithm. The review also cites several attempts to determine the true prevalence of this de debilitating condition that is estimated to affect tens of millions of people worldwide. BCD has been identified as a common consequence of childbirth and the aging process and is the second leading cause of institutionalization in the US.

  For more information, visit www.touchgastroenterology.com. This article was not subject to the Ostomy Wound Management peer-review process.