LAM Pharmaceutical Corporation is pleased to announce that the company has received permission to market its proprietary, patented wound product, LAM IPM(TM) Wound Gel, pursuant to the Section 510(k) (FDA assigned number K020325). The letter from the FDA, the Department of Health and Human Services, Division of General, Restorative, and Neurological Devices, Office of Device Evaluation, Centre for Devices and Radiological Health, was dated April 15, 2002, and was received by the company on April 17, 2002.
LAM IPM Wound Gel has demonstrated in human trials an 88.0-percent rate of effectiveness in creating the necessary environment for wound healing of refractory (hard-to-heal) leg and foot ulcers. The incidence of these types of ulcers is increasing rapidly, as the baby boom generation ages and people live longer. Last year, 26 million ulcers were reported in the United States alone, of which approximately six million have been estimated as being chronic, difficult to heal, and requiring thousands of dollars in total treatment costs.
LAM IPM Wound Gel is a clear, viscous, odorless, aqueous gel composed principally of sodium hyaluronate, a derivative salt of hyaluronic acid.
Indications for over-the-counter use of LAM IPM Wound Gel include minor abrasions and minor cuts. Under the supervision of a healthcare professional, LAM IPM Wound Gel is suitable for exuding wounds, such as leg ulcers, pressure ulcers, diabetic ulcers, and management of mechanically or surgically debrided wounds.
For more information, contact LAM Pharmaceutical Corp., Professional Services Department, 755 Center Street, Unit 5, Lewistown, NY 14092; phone (877) 526-7717 or (716) 754-2002; or visit www.lampharm.com. |