The Food and Drug Administration (FDA) recently cleared the Versatile 1 Wound Vacuum System from BlueSky Medical, La Costa, CA, for marketing. The system applies localized negative pressure to the wound bed to promote healing. The Centers for Medicare & Medicaid Services (CMS) has also approved reimbursement of the Versatile 1 Pump and accessory kits. This will allow the company's dealer base to use the assigned codes for Medicare reimbursement purposes.
[black up pointing small triangle] Information:http://www.blueskymedical.com
Wright Medical Group, Inc, Arlington, TN, has received reimbursement approval from the CMS for 2 of its wound care products. The GRAFTJACKET Ulcer Repair Matrix will have code "C9221," and code "C9222" is assigned to GRAFTJACKET XPRESS Flowable Soft-Tissue Scaffold.
GRAFTJACKET's Ulcer Repair Matrix is designed to allow healing at deeper levels, while protecting the external layer of the wound with a graft material that converts into functional host tissue. The GRAFTJACKET XPRESS Flowable Soft-Tissue Scaffold can be administered easily through a syringe to quickly fill the voids in the wound, creating a barrier against infection and providing a bioactive scaffold to aid in tissue formation.
[black up pointing small triangle] Information:http://www.wmt.com
Hill-Rom, Batesville, IN, has signed a new license agreement with Span-America Medical Systems, Inc, Greenville, SC, to develop and manufacture a therapeutic support surface for Hill-Rom's VersaCare Bed System. Introduced earlier this year, the system is a full-featured hospital bed designed to help deliver effective wound therapy and improve patient and caregiver safety in acute care environments.
[black up pointing small triangle] Information:http://www.hill-rom.com
BioElectronics Corporation, Frederick, MD, has been recommended for International Standards Organization certification. The company is the developer and marketer of the ActiPatch Therapy medical devices.
[black up pointing small triangle] Information:http://www.bioelectronicscorp.com.
Kensey Nash Corporation, Exton, PA, has received 510(k) approval for its BioBlanket Surgical Mesh, allowing sale of the product in the United States. The resorb-able collagen sheet technology is intended for use in surgical procedures as a patch for reinforcement and repair of ruptured or damaged soft tissue.
Potential applications include a wide variety of general surgical, reconstructive, and urogynecologic procedures such as hernia repair, bladder slings for the treatment of stress urinary incontinence, and the repair of pelvic floor defects.
[black up pointing small triangle] Information:http://www.kenseynash.com
Johnson & Johnson Consumer France SAS, Issy-Les-Moulineaux, France, a subsidiary of Johnson & Johnson, has acquired Biapharm SAS, Houdan, France. Biapharm is a producer and marketer of skin care products centered on their leading brand, Biafine, which is the best-known skin-healing brand on the French market, according to the company. Biapharm's main operating company, Laboratoire Medix, also markets other skin care and healing products.
[black up pointing small triangle] Information:http://www.jnj.com
Novartis Pharma AG, Basel, Switzerland, has received marketing authorization from the European Commission for darifenacin hydrobromide (Emselex), 7.5 mg and 15 mg, for the treatment of overactive bladder. Novartis will be able to market Emselex in all 25 European member states, as well as in Norway and Iceland. A once-daily M3 selective receptor antagonist, Emselex has been shown to reduce weekly incontinence episodes by up to 77% versus placebo. To date, 97 clinical trials of Emselex have been conducted, involving more than 10,500 subjects.
[black up pointing small triangle] Information:http://www.novartis.com