New Products and Industry News

Hydrofiber dressing introduced in Europe

  ConvaTec (Skillman, NJ), announced the availability of AQUACEL® EXTRA™ wound dressing with strengthening fiber in certain countries in Europe. The company introduced the new dressing during the 22nd Conference of the European Wound Management Association (EWMA) in Vienna, Austria, May 23–25, 2012. The new product is already available in several countries throughout Europe including Germany, Spain, United Kingdom, Ireland, and the Benelux and Nordic regions. The company has plans to continue to expand this launch throughout the European region throughout the year.   The dressing is constructed with two-dimensional strengthening fibers stitched into the dressing. Although they are made from the same base material used to manufacture Hydrofiber® Technology, the strengthening fibers do not gel on contact with fluid, so they maintain integrity and become encompassed by the gel, providing additional strength and aiding the easy removal from wound beds. This structure makes it nine times stronger and increases absorbency 39% over current AQUACEL® wound dressings. The product is cleared for the same indications as AQUACEL® wound dressing products, with specific suitability for managing moderate to highly exuding wounds. The dressings are available in four sizes: 5 cm x 5 cm, 10 cm x 10 cm,10 cm x 12 cm, and 15 cm x 15 cm.

  For more information, visit: www.convatec.com.

Multicenter NPWT clinical trial results announced

  The final results of a 17-center prospective, randomized, controlled clinical trial featuring Spiracur Inc’s (Sunnyvale, CA) SNaP® Wound Care System have been published in the May-June 2012 issue of Wound Repair and Regeneration. The study evaluated the product’s safety and efficacy for the treatment of chronic lower extremity wounds and its non-inferiority compared to the electrically powered KCI V.A.C.® Therapy System (KCI, San Antonio, TX).

  This first-ever comparative effectiveness study of its kind in the field was performed under the guidance of David G. Armstrong, DPM, MD, PhD; William A. Marston, MD; Alexander M. Reyzelman, DPM; and Robert S. Kirsner, MD, PhD. It involved 132 patients with lower extremity wounds randomly assigned to treatment with either the SNaP or VAC systems. Of the 118 patients who received treatment, 115 had follow-up data available for analysis, and 83 patients completed the study with either healing (complete closure of the ulcer) or 16 weeks of therapy.

  For more information, www.spiracur.com visit.

Clinicians trained in new diagnostic wound test

  More than 1,000 clinicians from 400+ sites across Europe, the Middle East, and South Africa have been trained on Systagenix’s (Gatwick, UK) WOUNDCHEK™ Protease Status since its launch 4 months ago. The product is the world’s first point-of-care test for elevated protease activity (EPA) in chronic wounds.

  The test is a much-awaited adjunct to current clinical diagnosis and assessment; EPA cannot be detected by visual cues. Recent clinical trial data have shown that a chronic wound with EPA has a 90% probability of not healing without appropriate intervention to lower protease activity. Among the nonhealing wounds in the clinical trials, 28% had EPA. The new diagnostic will allow clinicians to identify patients with EPA more quickly and prescribe the appropriate therapy.

  The test is not currently cleared by FDA for sale within the US market.

  For more information, visit www.systagenix.co.uk.

Medicinal honey improves wound healing, decreases pain

  A new prospective, observational study published online in the International Wound Journal found that medicinal honey can promote healing and reduce the affected area of many wounds when used as a secondary dressing. The study was financed in part by Derma Sciences (Princeton, NJ), a manufacturer of Medihoney, the line of dressings containing active Leptospermum honey from New Zealand.

  For more information on the study, visit: www.medscape.com/viewarticle/762958.

One-piece drainable pouch now comes in smaller size

  Marlen Manufacturing and Development Company (Bedford, OH) has introduced MiniMax™, a one-piece, disposable drainable pouch that is 30% smaller than the company’s previous product.

  The pouch is available with either a shallow convex or flat flange. The Cut-To-Fit design features a 12-mm starter hole. The pouch may be ordered with an opaque material on the back of the pouch that includes an exclusive Kwik-View™ “Peek-a-boo” feature that allows quick accessibility to view the interior of the pouch or a transparent material on the back of the pouch.

  For more information, visit www.marlenmfg.com.

Proposed National Coverage Determination issued for PRP gel

  The Centers for Medicare and Medicaid Services (CMS) issued a proposed National Coverage Determination (NCD) memo for autologous blood-derived products for chronic nonhealing wounds. In its decision memo, the CMS proposed coverage through its Coverage with Evidence Development program for all three major wound categories: diabetic, venous, and pressure wounds.

  The release of the proposed NCD memo follows 6 months of CMS analysis and consideration, subsequent to formal approval of a reconsideration request made by Cytomedix, Inc (Gaithersburg, MD) and several clinical practitioners and industry opinion leaders.

  Cytomedix’s comprehensive request for Medicare coverage reconsideration proposed that clinical evidence is sufficient and compelling to validate the use of autologous PRP gel to treat chronic, nonhealing pressure ulcers, venous ulcers, and diabetic foot ulcers. The request presents the reasons why PRP gel significantly and reliably improves the rate of complete healing, speed and progress to healing, and quality of life as compared with standard wound care in the Medicare-eligible population.

  For more information, visit www.cytomedix.com.

Chronic wound treatment device receives award

  Electrochemical Oxygen Concepts (EO2™ Concepts, San Antonio, TX) has been added to Marathon Medical’s (Commerce City, CO) existing Federal Supply Schedule (FSS) contract, administered by the Department of Veterans Affairs (VA). The TransCu O2®, an FDA-cleared Class III medical device, is a noninvasive, electrochemical low-dose tissue oxygenation system for the treatment of difficult-to-heal wounds. It is now available to all organizations that purchase from the FSS, including the entire federal healthcare system, the largest healthcare provider in the United States with more than 1,300 veterans health facilities, Department of Defense medical treatment facilities, military hospitals, and Indian Health Service Hospitals.

  For more information, visit www.eo2concepts.com.

Cleveland Clinic “Cleveland” named Center of Excellence

  The National Association For Continence (NAFC [Charleston, SC]) has designated the Section of Female Pelvic Medicine and Reconstructive Surgery in the OB/GYN and Women’s Health Institute and the Colorectal Surgery in the Digestive Disease Institute (DDI) at the Cleveland Clinic a Center of Excellence (COE): Continence Care for Women.

  The DDI’s Department of Colorectal Surgery is globally recognized as a national leader in colorectal surgery and surgical innovation, attracting patients from more than 46 states. Cleveland Clinic’s DDI is the first to unite all specialists within one unique, fully integrated model of care aimed at optimizing patient experience. The DDI includes colorectal surgery, general surgery, hepato-pancreato-biliary and transplant surgery, gastroenterology and hepatology, and the Center for Human Nutrition. Nearly 50 years ago, DDI created the Wound, Ostomy, Continence Nursing School, the first of its kind in the world and a forerunner of the WOCN society of nurses with whom NAFC closely collaborates.

  For more information, visit www.nafc.org.

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