A label amendment for the Versajet Hydrosurgery System (Smith & Nephew, Largo, FL), an advanced surgical wound management product, has been approved by the US Food and Drug Administration. The product is already approved for the surgical debridement of a variety of chronic and acute wounds. Now Versajet has been cleared for a burn debridement indication.
The waterjet-powered surgical device delivers a hair-thin stream of fluid to supersonic speeds, enabling surgeons to simultaneously grasp, cut, and remove damaged tissue and contaminants without collateral tissue damage. According to the manufacturer, the system is used for wound debridement in many surgical specialties, including orthopedic, vascular, podiatric, plastic, and general surgery.
[black up pointing small triangle]Information:http://www.smith-nephew.com
AcryMed, Inc, Portland, OR, demonstrated new technology that delivers oxygen into wound sites to promote healing at the recent Wound Healing Society Meeting in Scottsdale, AZ. Called Oxygenesys TDO (Topical Dissolved Oxygen System), the new dressings can supply significant amounts of dissolved oxygen to the wound, according to the company. Studies conducted on human donor skin have shown that using Oxygenesys TDO allows sufficient oxygen to penetrate deep into tissues to counteract the oxygen deficiency chronic wounds may encounter, according to Dr Bruce Gibbins, founder and chief technical officer at AcryMed. Results also indicated that the technology permeates the skin tissue at a rate that is at least 3 times higher than the level delivered by blood. Dr Gibbins added that AcryMed plans to work directly with device manufacturers and expects to have an oxygen delivery system of this kind on the market soon.
[black up pointing small triangle]Information:http://www.AcryMed.com
After receiving approval for sale in the United States from the US Food and Drug Administration, the Epi-Max acetylated regenerated cellulose sterile wound dressing has generated positive initial feedback in current clinical evaluations. The prescription combination device provides the benefits of an innovative wound dressing with dual active ingredients, according to its manufacturer, Dermagenics, US, Inc, a wholly owned subsidiary of Greystone Pharmaceuticals, Inc, Memphis, TN. Epi-Max is indicated to manage pressure, venous, and diabetic ulcers; skin irritations; cuts; and abrasions. Clinical evaluations are expected to continue into early 2007.
[black up pointing small triangle]Information:http://www.greystonemedical.com
Advancis Pharmaceutical Corporation, Germantown, MD, has received approval from the US Food and Drug Administration to market 2 new strengths of its antibiotic Keflex (cephalexin). The drug was expected to be available in 333-mg and 750-mg capsules starting in July 2006. Keflex is the most commonly prescribed oral cephalosporin antibiotic and is also the most recommended oral antibiotic therapy for uncomplicated skin and skin structure infections, according to the manufacturer.
[black up pointing small triangle]Information:http://www.advancispharm.com/products/keflex
Misonix, Inc, Farmingdale, NY, has entered into a distribution agreement with Medline Industries, Mundelein, IL, for the SonicOne Ultrasound Wound Debridement System, giving Medline the exclusive distributing rights for the product in the United States. The SonicOne allows health care practitioners to remove necrotic tissue, biofilm, and other impediments to successful wound healing. Misonix developed and manufactures the product.
[black up pointing small triangle]Information:http://www.misonix
Smith & Nephew's Advanced Wound Management division, Hull, England, and Largo, FL, announced the European launch of its new versions of Allevyn Adhesive and Allevyn Sacrum, which offer up to 3 times their increased fluid handling capacity. The Allevyn Adhesive dressings will now have more breathable top film and a faster rate of fluid uptake to help deliver an optimal moist wound environment for the promotion of faster healing, according to the manufacturer.
[black up pointing small triangle]Information:http://www.smith-nephew.com
The US Food and Drug Administration has approved Coaptite Injectable Implant (Boston Scientific Corporation, Natick, MA, and BioForm Medical, Inc, San Mateo, CA) for the treatment of female stress urinary incontinence. The 2 companies have also signed an agreement granting Boston Scientific exclusive US distribution rights for the implant, which is expected to launch immediately. The Coaptite Injectable Implant is a next-generation bulking agent that combines calcium hydroxylapatite particles and the sodium carboxymethylcellulose carrier gel to form a scaffold that promotes tissue infiltration.
[black up pointing small triangle]Information:http://www.bostonscientific.com