New Products and Industry News October
Antimicrobial dressings minimize patient pain and trauma
Smith & Nephew’s Advanced Wound Management Division (Hull, UK) is launching two extensions to the Allevyn Ag™ range of dressings — Allevyn Ag™ Gentle Border and Allevyn Ag™ Gentle. These dressings combine the antimicrobial protection of silver with the gentleness of silicone and soft gel adhesives specifically designed to minimize patient pain and trauma to the wound at dressing removal. These dressings are available in a range of sizes and offer patients and clinicians key benefits of antimicrobial protection to help fight infection, minimal pain during dressing changes, and superior fluid management.
The two dressings afford patients a complete range of foam dressings for infected and noninfected wounds; clinicians can offer a clinically proven and cost-effective solution for all customers’ foam dressing needs.
For more information, visit www.smith-nephew.com.
Advanced adhesives are available for wound and surgical care
Avery Dennison Specialty Tape Division (Pasadena, CA) recently introduced two new ultrathin adhesives and a hydrocolloid and adhesive technology solution. Designed for use across the entire spectrum of wound care and for the most demanding surgical applications, the company’s specialty tape medical division products generated a great deal of interest among Chinese manufactures of surgical tape and dressings for acute and chronic wound care and consumer applications. Ultrathin adhesive solutions provided excellent fluid handling capacity at a 100-micron thickness to facilitate flexibility in design for consumer dressings and skin patches. MED 5568H is optimized for foot care applications that require extra adhesion under tough conditions. MED 5573H is specially designed for optimal skin adhesion on hands and other more delicate parts of the body. These ultrathin adhesives can be combined with the company’s hydrocolloid technology to equal or surpass the fluid-handling capacity of the much thicker traditional formulations.
The medical technology sector is booming in China and is fueled by massive domestic demand and the promise of huge international markets for high-quality, cost-effective medical devices. To specifically help manufacturers in China grasp these huge opportunities, the company is introducing the very latest in pressure-sensitive medical tape and adhesive products.
For more information, visit www.averydennison.com.
Silver dressings address disease and infection
I-Flow Corporation, through its wholly owned subsidiary AcryMed Inc (Beaverton, OR), announced the availability of its family of four conveniently sized ON-Q® SilverDressings™. These thin film dressings contain ionic silver that is 99.99% effective in killing or inhibiting the growth of a wide range of micro-organisms, including methicillin-resistant Staphylococcus aureus, for up to 7 days. The added layer of antimicrobial protection might reduce the risk of infection, which may help facilities avoid incremental treatment costs. The dressings have a moisture vapor transmission rate (MVTR) well above that of standard dressings. Their greater breathability plus low friction surface means a more comfortable experience for the patient/dressing wearer, as well as potentially longer wear time. In addition to surgical site care and incisional catheter applications, the dressings also are recommended for clinical applications where the risk of infection is a concern, including catheter securements for peripheral IV, central lines, epidurals, and PICCs/midlines. The dressings create a physical barrier that helps prevent microbes on the dressing, potentially shielding the wound site from infection.
For more information, visit www.AcryMed.com.
First randomized clinical trial results for powder dressing announced
Uluru Inc (Addison, Tex) presented results from the first completed randomized clinical trial for Altrazeal™ Transforming Powder Dressing at the Symposium on Advanced Wound Care (SAWC) Fall Symposium, which took place in Washington DC, September 16–18, 2009. The dressing utilizes proprietary nanoflex™ technology to promote the healing of exuding wounds. The recently completed clinical study compared healing, pain, and comfort of skin graft donor sites treated with either the dressing or with a leading commercial sodium carboxymethylcellulose-silver (“CMC-Ag”) dressing. Major results from the study indicated a significant difference in patient’s pain scores, all favoring the dressing with lower pain scores at each time point (P <0.001). When asked about the comfort of the wound dressing at the edges, study subjects rated the dressing more comfortable (P <0.001) and less painful when the dressing came in contact with clothes or bedding (P <0.001). The study endpoints validated the hypothesis for time to healing for both dressings in this particular type of acute surgical wound.
The study was a single center, prospective randomized trial in which each patient served as his/her own control. Each patient had at least two split-thickness donor sites: one was dressed with the study dressing and the other with the CMC-Ag dressing. In addition to the randomized clinical trial, more clinical evidence on the treatment of various wound types using the transforming powder dressing were presented on multiple posters during the symposium.
For more information, visit www.uluruinc.com.
New wound care product for clinicians and patients
Oculus Innovative Sciences Inc (Petaluma, CA) recently launched Microcyn® Skin & Wound HydroGel for both the US professional and over-the-counter (OTC) markets. The gel received FDA 510(k) marketing clearance in May 2009. The Microcyn® Skin & Wound HydroGel for professional use is intended for the management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, first-and second-degree burns, and mechanically or surgically debrided wounds. It is reimbursable per Medicare HCPCS #A6248. Microcyn® Skin & Wound HydroGel OTC is intended for use by consumers on minor skin abrasions, lacerations, minor irritations, and intact skin. A national advertising campaign will continue throughout the year. The original Microcyn-based solution, branded as Microcyn Skin & Wound Care with preservatives (HCPCS #A6260) in the US, Microdacyn60™ in Mexico, Dermacyn™ Wound Care in Europe and China, and Oxum in India, has treated more than one million patients worldwide without a report of a single serious adverse effect.
For more information, visit www.oculusis.com.
Company pursuing Japanese market
Kinetic Concepts Inc (San Antonio, TX) announced that the Ministry of Health, Labor and Welfare (MHLW) will grant regulatory approval of market development activities at the Pharmaceutical and Medical Devices Agency (PMDA) in Japan for its V.A.C.® Therapy product.
The company anticipates the MHLW will ensure that all necessary regulatory steps have been addressed before the application is taken to the Minister’s Office for a signature. Following regulatory approval, the company expects reimbursement will be provided in the first half of 2010. Once reimbursement approval is obtained, the company will officially begin marketing the therapy in Japan. The company’s vision is to transform wound care in Japan by delivering advanced healing solutions and clinical know-how in a way that produces unparalleled outcomes.
For more information, visit www.kci1.com.
Company sponsors compression therapy and venous disease-focused blog
Sigvaris (Peachtree City, GA) will sponsor a leg circulation, compression therapy, and venous disease management blog (www.veinhealthforum.org) as a continuing education resource for medical professionals. Medical topics and content related to compression therapy and venous disease are added regularly to the blog site. Medical professionals and industry experts including Dr. Samuel Martin, FACS; Dr. Mark D. Forrestal, FACph; and Dr. Michael F. Burke, FACS, assist in moderating and authoring content for the company-sponsored compression therapy and leg vein health medical forum.
The company is pleased to sponsor the Leg Circulation and Vein Health Forum, which is a compression-industry first designed for healthcare professionals to secure information regarding vein issues, procedures, treatment, and management of this progressive disease.
For more information, visit www.sigvarisusa.com.
Company outlines strategic growth plan to set professional precedence
Advanced BioHealing Inc (Westport, CT) announced a strategic growth plan designed to continue to transform the company into a leading international regenerative medicine company. The company manufactures and markets Dermagraft®, a bioengineered skin substitute that repairs tissue damage caused by disease or injury and supports the body’s natural healing process in patients with diabetic foot ulcers. To spur future growth, executive management has outlined a growth strategy to leverage current successes, develop its international presence, address new applications, and expand its product line; three key goals include continuing the expansion of company sales, extending product use for multiple indications, and diversifying the product portfolio.
The company continues to build its sales and marketing infrastructure by recruiting top sales professionals from inside the pharmaceutical and medical device industries. The company also is working with industry peers to promote regulatory, research, and reimbursement policies that foster innovation in regenerative medicine and educate at-risk populations of senior citizens and patients suffering with diabetes. A corporate identity program designed to position the company as a leading regenerative medicine company complete with new logo, tagline, web site, and public relations campaign is now in place.
For more information, visit www.Dermagraft.com.
Biotechnology company acquired
Wound Management Technologies Inc (Fort Worth, TX) completed the acquisition of BioPharma Management Technologies Inc, a privately held biotechnology company with a platform of proprietary and patented technologies for topical pain management and resorbable orthoses.
BioPharma’s proprietary technologies and its future products are complementary to Wound Management Technologies’ major product, CellerateRx®, a collagen hydrolysate polypeptid whose patented collagen fragments, which are a fraction of the size of the native collagen molecules and particles found in other products, deliver the benefits of collagen. The polypeptid is used in the management of pressure ulcers, traumatic wounds, diabetic ulcers, first- and second-degree burns, venous stasis ulcers, ulcers due to arterial insufficiency, and superficial wounds.
For more information, visit www.celleraterx.com.