April New Products & Industry News

Hydrofera and Hollister Wound Care Announce Exclusive dressing Distribution Agreement

  Hollister Inc (Libertyville, IL) and Hydrofera LLC (Fort Worth, TX) recently announced the signing of an exclusive distribution agreement for Hydrofera Blue® Advanced Wound Care products. As part of the agreement, Hollister Wound Care LLC has exclusive rights to market, sell, and distribute the Hydrofera Blue Dressings as of March 1, 2011.

  This exciting venture is another enhancement to Hollister’s growing line of advanced wound care products that provide both clinical and economical value to their customers. While many customers have already benefited from using the product, the company is eager to increase the awareness of the technology.

  Hydrofera Blue Dressings are bacteriostatic dressings that are proven effective in inhibiting the growth of microorganisms commonly found in wounds, including MRSA and VRE. These dressings are produced through a patented process combining PVA foam with two organic pigments, Methylene Blue and Gentian Violet. The construction provides a matrix that allows the dressing to absorb wound exudate and provide broad-spectrum bacteriostatic protection. The dressings are a powerful addition to company’s extensive wound care offering.

  Visit www.hydrofera.com or www.hollisterwoundcare.com for more information.

Recently Published Study Highlights Significant Improvement in Chronic Wound Care Options

  Spiracur® Inc (Sunnyvale, CA), the developer of an ultraportable and disposable negative pressure wound therapy (NPWT) device, recently announced encouraging interim results from a clinical study highlighting the safety and efficacy of its SNaP® Wound Care System for the treatment of chronic lower extremity wounds. The 12-center randomized-controlled trial (RCT) 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. The purpose of the study was to compare the ultraportable mechanically powered SNaP (Smart Negative Pressure) Wound Care System to the traditional electrically powered Vacuum-Assisted Closure (V.A.C®) Therapy System in the treatment of chronic lower extremity wounds. The trial enrolled 65 patients with lower extremity wounds who were randomly assigned to treatment with either the SNaP or V.A.C Systems. The trial evaluated treatment for up to 16 weeks, or until there was complete closure of the ulcer. The results from this trial are important for those dedicated to healing wounds and preventing amputations, as the SNaP System offers an important tool for treating such chronic conditions. This technology may prove to hold substantial potential for patients requiring smaller NPWT treatment options.

  Planned interim analysis of the first 65 patients from 12 centers found no significant differences in the proportion of subjects healed between the two devices evaluated or in percent wound size reduction. Non-inferiority was demonstrated between the two therapies in percent wound size reduction to the P

  Visit www.spiracur.com for more information.

Study Shows dermaPACE® is More Effective Than HBOT in Healing Outcomes of Chronic Diabetic Foot Ulcers

  Sanuwave Health Inc (Alpharetta, GA) recently announced the publication of research conducted in Taiwan comparing the effectiveness of the company's dermaPACE® device with hyperbaric oxygen therapy (HBOT) in treating chronic diabetic foot ulcers. The study, entitled "Treatment of Diabetic Foot Ulcers: A Comparative Study of Extracorporeal Shockwave Therapy and Hyperbaric Oxygen Therapy," by CJ Wang et al consisted of various key study findings. The dermaPACE device demonstrated significantly improved healing compared with HBOT (P =0.003). After one course of treatment, dermaPACE completely healed 24 ulcers compared with 10 ulcers that healed as a result of HBOT (2.4 times more). Following a second course of treatment, dermaPACE completely healed a combined 31 ulcers in comparison with 11 ulcers for HBOT (2.8 times more). After one course of treatment, a significantly greater number of ulcers treated with HBOT were unchanged in size and depth compared with ulcers treated with dermaPACE (P

  Perfusion (blood flow) significantly increased in the dermaPACE group after treatment (P

  Consequently, this study included notably sick patients who, absent successful medical treatment, may have been faced with surgical intervention, including limb amputation.

  Visit www.sanuwave.com for more information.

Pluristem Therapeutics and NYU Medical Center Partner to Study Use of PLX Cells in Treatment of Diabetic Foot Ulcers

  Pluristem Therapeutics Inc (Aifa, Israel) and New York University (NYU) Medical Center (New York, NY) announced the formation of a partnership to study the use of Pluristem’s proprietary placenta-derived PLX cells for the treatment of diabetic foot ulcers (DFU). Weiliam Chen, RPh, PhD, Director of the Tissue Engineering Research Laboratory, Department of Surgery at NYU’s Helen L. and Martin S. Kimmel Wound Healing Center, will be the principal investigator (PI) of these pre-clinical studies, which are the first step toward a future potential Phase II clinical study for treatment of DFU.

  An in vitro model and a series of animal models will be used to evaluate the role PLX cells have in healing DFU. Through a novel academic industrial collaborative research paradigm, these trials, with proposed support from the National Institutes of Health (NIH), will be used as a bridge towards the potential treatment of patients with diabetic foot ulcers. Diabetes affects over 170 million people worldwide and more than 20 million Americans with the prevalence expected to double by 2030. Chronic diabetic foot ulcers are the leading cause of lower extremity amputations and no new therapy for diabetic chronic wounds has been introduced into clinical use since 1998 and there is a critical unmet need for innovative therapies able to accelerate DFU healing, prevent amputation, and reduce associated morbidity and mortality. This partnership is important to developing an advanced cellular therapy as many diabetic patients have advanced atherosclerosis and have lower extremity vascular insufficiencies. Pluristem’s PLX cells can stimulate angiogenesis, which is highly advantageous in treating diabetic chronic wounds. The PLX cells can also directly address cellular impairment in diabetic wounds leading to tissue regeneration in the wound beds.

  Visit www.pluristem.com for more information.

National Alliance of Wound Care® Bestows First Advanced Credential in the Specialty of Diabetic Wounds

  The National Alliance of Wound Care ([NAWC®] Glendale, WI) has awarded the first diabetic wound certified (DWC®) credential to the group of wound care candidates who successfully passed the DWC certification examination. The DWC is the first advanced wound care certification in the specialty of diabetic wounds. Diabetic wounds occur below the ankle and are caused from the effects of the disease. These wounds develop primarily from loss of sensation in the foot and also as a result of reduced blood supply. The forward thinking of the NAWC now affords the opportunity for thousands of clinicians certified in wound care to obtain an advanced certification in diabetic wounds. The NAWC estimates nearly 800 candidates will receive their (DWC) board certification in 2011. The DWC credential demonstrates a wound care professional’s proficiency and mastery of essential knowledge and skills of diabetic wound management above basic wound care certification. Wound care professionals can now take their expertise, status, and careers to the next level with the DWC credential. The DWC is available to all wound care professionals who are currently wound care certified through a nationally accredited program.

  Visit www.nawccb.org for more information.

Product News

3M Skin & Wound Care Launches Soothing Antifungal Cream

  3M Skin & Wound Care (St. Paul, MN) recently introduced new 3M Cavilon Antifungal Cream, an easy-to-apply cream that effectively relieves skin discomforts due to fungal infections. Addressing the needs of incontinence caregivers and patients, this new cream offers a soothing solution to relieve redness, irritation, scaling, itching, and burning associated with fungal infections. The cream has been enriched with water-repelling ingredients, critically important for protecting vulnerable skin and ideal for assisting caregivers working in incontinence settings. The cream has been formulated with 2% miconazole nitrate, an active ingredient that has been clinically proven to treat tinea corporis (ringworm), tinea pedis (athlete’s foot), and tinea cruris (jock itch). The product is also approved for use on fungal infections caused by Candida albicans. In the fall of 2010 the entire Cavilon brand was updated with new, innovative packaging to help caregivers easily identify the right product for a specific need. Later this year 3M will be adding enhanced product formulations, sizes, and new patient-friendly delivery systems to the Cavilon line. This product addresses skin fungal infections with a barrier property that resists washing off. The cream fills a significant need for clinicians and their patients, and by launching this new product, the company is reinforcing its strong commitment to skin care.

  Visit www.3M.com/SkinHealth for more information.

Venous Health Systems Receives FDA Clearance to Commercialize Pneumatic Compression System

  Venous Health Systems Inc (Portola Valley, CA), developer of solutions for treating vascular insufficiency by enhancing blood circulation, recently announced that it has received 510(k) clearance from the FDA to market the Vasculaire™ Compression System in the United States. The compression system is a portable pneumatic device for treating vascular insufficiency. It features an innovative platform technology comprised of a fully portable pneumatic controller attached to a patented multi-cell compression sleeve. When the compression sleeve is placed on the patient’s calf and foot and the controller is activated, the cells promote circulation with a sequential rapid inflation wavelike motion. The increase in venous velocity achieved using the system tests well within the range of values reported by the market-leading sequential pneumatic compression system. Without airlines or power cords, the system represents a long-awaited solution for the hospital, extended care facility, and home markets.

  The new system delivers performance in a palm-sized unit directly attached to the patient’s calf sleeve. Unlike other pneumatic compression devices, which can weigh up to 12 lbs, this system weighs less than 1 lb, thereby enabling patient mobility and potentially leading to increased patient compliance. The system is also used as a prophylactic therapy to prevent deep vein thrombosis (DVT), as well as: enhancing blood circulation, reducing edema, diminishing post-operative pain and swelling, reducing wound healing time, the treatment of stasis dermatitis, venous stasis ulcers, and arterial and diabetic leg ulcers, and the treatment of chronic venous insufficiency.

  Contact info@venoushealth.com for more information.

Derma Sciences Receives FDA Clearance for Medihoney® Gel

  Derma Sciences Inc (Princeton, NJ) recently announced receipt of 510(k) clearance from the US Food and Drug Administration (FDA) for the company’s patent-pending Medihoney® Gel Wound and Burn Dressing. This latest Medihoney line extension is dispensed from a tube and is comprised of Active Manuka (Leptospermum) honey blended with natural-based gelling agents. This is an important addition to the company’s product offering and they expect the marketplace to embrace this new product as they strengthen category leadership. The gel will provide clinicians and patients with added versatility in their use of honey-based products for challenging wounds and burns. Because the product is blended with gelling agents, the honey is able to better maintain its physical integrity at the site of the wound, even in the presence of wound fluid and body heat. This will make for a more durable and lasting product, which is key in the management of chronic wounds. Importantly, its proprietary formulation utilizing natural gelling agents has a patent pending in the United States, which if granted, will further increase the company’s IP around the brand. Derma Sciences will manufacture the new gel in its facility in Toronto. This is the fourth product in the expanding franchise, and will be launched into the market by the company’s 20-person US sales force at all major annual wound conferences this spring.

  Visit www.dermasciences.com for more information.

Sage Introduces the Prevalon® Turn and Position System

  Sage Products Inc (Cary, IL) is launching an innovative new system to help protect patients in the ICU from sacral pressure ulcers that will also help prevent staff injuries due to turning and repositioning patients. The Prevalon® Turn and Position System stays under the patient throughout the hospital stay to assist healthcare workers with turning, repositioning, and boosting. The system has three parts: the Low-Friction Glide Sheet, which moves with the patient to make turning easier; the Microclimate Body Pad, a disposable pad that is placed under the patient to manage heat and moisture; and two 30-degree Body Wedges to easily position patients for pressure redistribution and to offload the sacrum.

  Risk factors for sacral pressure ulcers include reduced mobility, moisture, friction, and shearing. The turn system aids in preventing sacral pressure ulcers by offloading the sacrum. It manages moisture due to incontinence and other sources, in addition to helping minimize friction and shear on the patient.

  Frequent turning and positioning is critical to preventing sacral pressure ulcers, but it can be challenging for healthcare staff. Repositioning patients is associated with increased risk of pain and injury to staff, especially to the back. The new system requires 71% less effort to turn a patient compared to traditional methods using a draw sheet and pillows. It decreases nursing time needed for turning, requires fewer nurses, and helps improve compliance to turning/repositioning protocols.

  Visit www.sageproducts.com for more information.

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