New Products and Industry News

Dressings simplified for challenging wound sites

  Spiracur Inc (Sunnyvale, CA) introduced its SNaP SecurRing™ Hydrocolloid. This new product, a hydrocolloid shaped into a ring, is designed to facilitate fast and easy applications of the SNaP Wound Care System on uneven skin surfaces or wounds in challenging locations. The new hydrocolloid is intended for patients with chronic wounds such as diabetic foot ulcers or wounds to the plantar surface of the foot, as well as acute wounds, such as ray (toe) amputations. Designed to fill uneven skin surfaces and mold around wounds, it protects the periwound tissue from maceration and increases adhesion of the hydrocolloid dressing. The end result is a sterile wound care product that will decrease application time and cost by reducing the need for adjunct products necessary to protect the wound from excess moisture and leaks.

  Gary Rothenberg, DPM, CDE, CWS, (Miami Veterans Affairs Healthcare System, Miami, FL) will present a poster, “Advances for Negative Pressure Wound Therapy in Challenging Anatomic Locations,” at the Symposium for Advanced Wound Care (SAWC) in Denver, CO, May 1–5, 2013. The poster describes the utilization of NPWT on an anatomically challenging location that otherwise would have been difficult to seal.

  For more information, please visit www.spiracur.com.

Placental tissue-based product portfolio showcased

  BioD, LLC (Memphis, TN) introduced its BioDGenesis Micronized Tissue Matrix in March at the 2013 Annual Meeting of the American Academy of Orthopedic Surgeons in Chicago, IL. In addition, the company showcased its entire placental tissue-based product portfolio, including BioDfactor, BioDfence, BioDDryflex, and AmnioExcel.

  BioDGenesis Micronized Tissue Matrix is a cryopreserved injectable allograft derived from human placental tissues for use as a wound covering in the treatment of localized areas of joint inflammation or soft tissue injury. Primarily used in sports medicine applications, it has been developed to cover and protect the wound or localized area of inflammation and to provide a natural scaffold that facilitates the migration and proliferation of the patient’s own cells to the site of injury.

  For more information, visit www.biodlogics.com.

Scar management study follow-up completed

  Oculus Innovative Sciences, Inc (Petaluma, CA) completed the 112-day follow-up period in the company’s clinical trial for the management of hypertrophic or keloid scars. The 40-patient comparative, double-blinded, randomized clinical study was based on a Food and Drug Administration (FDA)-approved protocol. Patients were enrolled at four different US clinical sites in Albuquerque, NM, High Point, NC, Austin, TX, and College Station, TX.

  The company is encouraged by the initial clinical trial results from the scar management trial and expects to complete data analysis and submit the 510k application to the FDA for review within the next 60 to 90 days. In accordance with FDA regulations, the company expects to release the data immediately after completion of FDA’s review.

  The trial’s primary endpoint was to compare a uniquely formulated Microcyn Technology-based hydrogel to a dimethicone comparator using the Vancouver Scar Scale that measured vascularity, height/thickness, pliability, and pigmentation of scars. Secondary endpoints included the measurements of pain and itch and other reported adverse events and treatment satisfaction as reported by patients through a questionnaire. No direct product-related serious adverse events occurred in either arm during the study.

  For more information, visit www.oculusis.com.

Wound care customer program launched

  MediPurpose (Atlanta, GA) launched its advanced wound care customer program, ValuePlus, a complimentary program that will provide highly interactive consultation and educational resources to guide appropriate dressing selection and formulary development to help achieve better outcomes and lower costs.

  For more information, visit www.medipurpose.com.

AAWC provides educational brochure in Spanish

  The Association for the Advancement of Wound Care’s (AAWC) (Malvern, PA) latest patient education brochure on the prevention and treatment of pressure ulcers, Take the Pressure Off! has been translated into Spanish.

  The AAWC’s Public Awareness Task Force developed four educational brochures for the care of skin and the prevention and treatment of wounds. Widely used by clinicians as a resource for patients and their caregivers, all four brochures (The ABC’s of Skin and Wound Care, The Skin You’re In, Dress and Compress for Success, and Take the Pressure Off!) are now available in English and Spanish.

  The brochures can be purchased from the organization’s online store, and the materials are also available as PDF files within the professional and patient resource centers on the AAWC website. As long as the use is educational, anyone may download and print them on their own, free of charge and without permission.

  For more information, visit www.aawconline.org.

Wound management products reclassified in Europe

  Oculus Innovative Sciences, Inc (Petaluma, CA) has been granted a reclassification of the company’s CE Mark for the European formulation Dermacyn™ Wound Care. The reclassification was approved by the British Standards Institution, the world’s largest certification body and the Medicines and Healthcare products Regulatory Agency in the UK. Reclassified as a class III medical device, the products’ newest indication is for “use in the debridement, irrigation, and moistening of acute and chronic wounds, ulcers, cuts, abrasions and burns. Through reducing the amount of microorganisms and contributing to a moist environment, it enables the body to perform its own healing process.” Additionally, the actives in Dermacyn™ are classified in Europe as medicinal substances that may have a local antimicrobial effect.

  For more information, visit www.oculusis.com.

Life-cycle management plan expands wound care portfolio

  Alliqua, Inc (New York, NY) initiated a life-cycle management plan as the first phase in their portfolio expansion initiative. As part of this plan, Alliqua is making a number of product changes designed to increase adoption of SilverSeal® and Hydress® dressings. The company plan modifications are intended to address the needs of patients with a broader range of wounds as well as the specific needs of various clinical customers. Customers should expect to see the first of these updated dressings in May 2013. A 510(k) application with the FDA for clearance of SilverSeal® incorporating additional modifications is expected to be submitted by mid 2013, after which a decision from the FDA may be forthcoming as early as the end of the year.

  For more information, visit www.alliqua.com.

ISO certification granted for advanced wound care product

  Cardium Therapeutics (San Diego, CA) has received ISO 13485:2003 certification for its Excellagen® advanced wound care product from BSI, one of the world’s leading certification bodies. The ISO 13485:2003 certification is a stand-alone standard developed by the International Organization for Standardization that provides harmonized quality management systems requirements for manufacturers of medical devices. Cardium’s compliance with ISO 13485 represents an important next step forward to compliance with European regulatory requirements.

  For more information, visit www.excellagen.com.

This article was not subject to the Ostomy Wound Management peer-review process.