Empi, Inc. Launches New Incontinence Therapeutic Device Combining Surface Electromyography and Pelvic Floor Electrical Stimulation.SAINT PAUL, Minn.--(BUSINESS WIRE)--Sept. 24, 1997--Empi, Inc., a medical device manufacturer, today announced that the Food and Drug Administration has granted it clearance to market InnoSense(TM), a new device to treat incontinence using pelvic floor muscle reeducation Reeducation may refer to:
InnoSense is being introduced at the American Urogynecologic Society meeting in Tucson this week and will be shown at the International Continence continence /con·ti·nence/ (kon´tin-ens) the ability to control natural impulses.con´tinent
1. Self-restraint; moderation.
2. Society meeting this weekend in Yokohama. The product is in limited release and is expected to be available for worldwide distribution in January. This product has been developed to meet the needs of clinicians and patients seeking to combine the benefits of user feedback provided by electromyography electromyography
Process of graphically recording the electrical activity of muscle, which normally generates an electric current only when contracting or when its nerve is stimulated. with the achievement of a complete nonvolitional pelvic floor contraction using electrical stimulation. The product is priced to make it attractive for office, clinic or home use.
"InnoSense is another step forward in Empi's strategy to provide cost effective, non-invasive therapeutic options to women suffering with stress, urge or mixed incontinence," said Joseph E. Laptewicz, Empi's president and chief executive officer. "By combining electromyography and functional electrical stimulation Functional electrical stimulation (commonly abbreviated as FES) is a technique that uses electrical currents to activate nerves innervating extremities affected by paralysis resulting from spinal cord injury (SCI), head injury, stroke or other neurological disorders, in a simple-to-use, low cost, battery-powered system, Empi has redemonstrated its technological leadership position in the incontinence therapy market. Behavioral therapies are among the most clinically effective and cost effective options available to the 13 million women and men in America who suffer the often debilitating de·bil·i·tat·ing
Causing a loss of strength or energy.
Weakening, or reducing the strength of.
Mentioned in: Stress Reduction symptoms of urinary incontinence Urinary Incontinence Definition
Urinary incontinence is unintentional loss of urine that is sufficient enough in frequency and amount to cause physical and/or emotional distress in the person experiencing it. . Over 2 billion dollars is spent annually to manage this medical problem in the United States alone."
Laptewicz concluded, "Empi remains committed to making these new forms of conservative therapy available to patients suffering with functional disabilities like urinary incontinence. While many private payors, insurance companies, and health maintenance organizations around the country recognize and reimburse for therapy utilizing pelvic floor stimulation (PFS PFS,
n post facilitation stretch; therapeutic approach utilized during proprioceptive neuromuscular facilitation in which the patient begins the stretch midway between the fully relaxed and fully stretched position and uses maximum level of effort to ), Empi continues to engage in a dialogue with HCFA HCFA
Health Care Financing Administration
n.pr See Health Care Financing Administration. to establish a favorable national coverage policy decision for Medicare patients using PFS. Cost savings associated with the use of PFS have been shown to be substantial while achieving a high degree of patient satisfaction."
Certain statements made in this press release relating to the availability of the InnoSense device in January and its ability to meet the needs of clinicians and patients are forward-looking statements and are subject to risks and uncertainties relating to unforeseen development and production delays.
Empi, Inc. develops, manufactures, and markets non-invasive biomedical bi·o·med·i·cal
1. Of or relating to biomedicine.
2. Of, relating to, or involving biological, medical, and physical sciences. devices and accessories for use in the physical therapy, sports medicine, and incontinence treatment markets. The company's shares are traded on the Nasdaq Stock Market's National Market under the symbol EMPI.
CONTACT: Empi, Inc., St. Paul
Patrick Spangler, 612/415-7404