Industry News December 2009

Advanced BioHealing Inc (Westport, Conn) has initiated a pivotal trial of Dermagraft® in subjects with venous leg ulcers (DEVO-Trial) to assess the product’s safety and efficacy in the promotion of healing venous leg ulcers (VLUs). Dermagraft is a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process. It is FDA-approved for the treatment of diabetic foot ulcers (DFUs) and used in more than 1000 wound care and outpatient clinics in the US. The international pivotal trial will enroll more than 400 patients in eight countries, making it the largest randomized, controlled, clinical study on a skin graft and/or bioengineered skin replacement planned to date. It is designed as a prospective, multicenter, randomized, controlled clinical study, in which subjects are assigned into one of two groups. The experimental group receives weekly applications of Dermagraft and four-layer compression dressings only. The company has initiated patient enrollment and activated 30 clinical centers globally and expects the study to be complete by May 2011.

Visit www.ABH.com for more information.

Kinetic Concepts Inc (San Antonio, Tex) recently announced that the Ministry of Health Labor and Welfare (MHLW) in Japan has granted final regulatory approval for the company to market and sell its renowned V.A.C.® Therapy System in the country. Japan has a deep heritage of providing outstanding medical care and the professionals of KCI are pleased to have the opportunity to serve this unmet medical need within Japan for difficult to heal wounds. Reimbursement applications have been submitted following regulatory approval. Operational preparations such as employee hiring are underway for a commercial launch at the time of reimbursement approval. The company anticipates reimbursement approval in the first half of 2010.

Visit www.kci1.com for more information

The Advanced Wound Management division of Smith & Nephew (St. Petersburg, Fla), a subsidiary of Smith & Nephew applauded the federal government’s decision to maintain the current, single reimbursement code for negative pressure wound therapy (NPWT) devices. The decision, announced by the US Centers for Medicare & Medicaid Services (CMS), affirms the conclusion reached by the Agency on Healthcare Research & Quality (AHRQ) earlier this year. AHRQ, like CMS, concluded that evidence does not exist to determine a significant therapeutic distinction between NPWT systems. As a result, CMS decided to maintain a single code for NPWT product components, including the canister and the wound care set. Separate from this decision by CMS, Smith & Nephew recently highlighted results of a multi-center study demonstrating that gauze-based NPWT achieves many of the common treatment goals defined for foam-based NPWT systems, including a reduction in wound dimension and exudate, improvement in granulation tissue, and enhancement of skin graft take.

Visit www.smith-nephew.com for more information.

Hill-Rom (Batesville, Ind) and Encompass Group (McDonough, Ga) recently formed a joint business venture that will focus on the sale and distribution of a comprehensive range of surface replacement systems that are intended to be sold separate from a bed frame and as replacements for surfaces that are technologically obsolete or at the end of their useful life. Hill-Rom brings its 80 years of expertise and innovation in the areas of therapeutic and prevention surfaces together with Encompass’s leading specialty in healthcare textiles and therapeutic and prevention surfaces. Together, the entities will form a new jointly owned company, Encompass TSS, LLC.      

Encompass TSS will become the exclusive distributor of all but the most complex of Hill-Rom’s capital surfaces in the after-market replacement segment in North America Acute Care. It is also expected that the joint venture will serve as the primary distribution channel for surface replacement products that Hill-Rom develops in the future. Encompass TSS will remain in place as a key supplier for Hill-Rom for non-powered and powered air support surfaces that are sold in combination with a new bed frame. The new company will continue to operate with headquarters at its current location in Pasadena, California and the sales force will be expanded.

Visit www.hill-rom.com for more information.

3M Skin & Wound Care Division (St. Paul, Minn) announced that the American Medical Association (AMA) has created a new Category I Current Procedural Terminology (CPT) code that will describe the application of 3M™ Coban™ 2 Layer Compression System; CPT code 29581—“Application of multi-layer venous wound compression system, below the knee.” The code will become effective January 1, 2010. AMA’s decision is a significant step as it will enable the clinician to choose the compression bandage most appropriate for treating the patient’s problem rather than basing it on reimbursement, and it will allow many patients to receive compression therapy when it otherwise may not have been available. In addition to the publication of the CPT code, the Centers for Medicare and Medicaid Services (CMS) released the Outpatient Prospective Payment final rule (CMS-1414-FC) and CPT code 29581 has been assigned to the APC payment group 0058, which has a 2010 payment rate of $71.03.

Visit www.3m.com/Coban2Layer for more information.

Deaths and serious complications, especially bleeding and infection have been associated with the use of Negative Pressure Wound Therapy (NPWT) systems. Although rare, these complications can occur wherever NPWT systems are used, including acute and long-term healthcare facilities and at home. The US Food and Drug Administration (FDA) has received reports of six deaths and 77 injuries associated with NPWT systems over the past two years. NPWT systems are generally indicated for the management of wounds, burns, ulcers, flaps, and grafts. They apply negative pressure to the wound in order to remove fluids including, wound exudates, irrigation fluids, and infectious materials. They are contraindicated in the presence of exposed anastomotic sites, exposed vasculature, exposed nerves, exposed organs, necrotic tissue with eschar present, untreated osteomyelitis, non-enteric and unexplored fistulas, and malignancy in the wound.      

It is recommended that patients be monitored frequently in an appropriate care setting by a trained practitioner. In determining the frequency of monitoring, the patient’s condition as well as wound status, wound location, and co-morbidities must be considered. Skilled care professionals should be vigilant for potentially life-threatening complications such as bleeding and be prepared to take prompt action if they occur. Appropriate training prior to the prescribing and use of NPWT must be obtained and if the patient is determined a proper candidate for using the NPWT system at home, the following should be adhered to:    

• Instruct the patient and/or caregiver about how to use the system, potential complications and their signs/symptoms, and what to do if complications occur.
• Request that the patient and/or caregiver demonstrate use of the system, and document his/her proficiency.      
• Assure that the patient and/or caregiver understands the warnings associated with NPWT system use.      
• Provide the patient with a written copy of the patient labeling from the NPWT system manufacturer, if available.

Encourage the patient to keep these materials and instructions for use readily accessible.

For more information, visit https://www.fda.gov/MedicalDevices/ Safety/AlertsandNotices/PublicHealthNotifications/.