Influence announces 510k approval of In-Fast bone screw system for female incontinence.SAN FRANCISCO--(BW HealthWire)--April 28, 1997--Influence Inc. announced that it has been granted 510K approval by the Food and Drug Administration to begin marketing In-Fast, its proprietary, single-patient-use bone screw system for incisionless, transvaginal cystourethropexy (bladder neck Bladder neck The place where the urethra and bladder join. Mentioned in: Urinary Incontinence fixation) and sling procedures. The In-Fast system In-Fast system Urogynecology A bone screw system for incisionless, transvaginal cystourethropexy and sling procedures for ♀ urinary incontinence. See Incontinence. supplements Influence's recently 510k approved In-Tac system that uses bone anchors and a reusable inserter for bladder neck fixation and sling procedures. 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. is characterized by the involuntary loss of urine. In 1995, an estimated 140,000 surgical procedures were performed for the treatment of female incontinence. One of the drawbacks of current suspension and sling surgical procedures is that they require either abdominal incision and/or vaginal dissection to some degree. Peter Bick M.D., president and chief executive officer of Influence, predicts the In-Fast and In-Tac procedures will revolutionize how surgeries for female incontinence are performed. These new, incisionless procedures are performed entirely transvaginally, in 15 to 30 minutes under local, spinal or general anesthesia Anesthesia, General Definition General anesthesia is the induction of a state of unconsciousness with the absence of pain sensation over the entire body, through the administration of anesthetic drugs. . Dr. Brick also commented, "There was an extremely high level of interest in our products at the recent American Urology urology Medical specialty dealing with the urinary system and male reproductive organs. It traces its origin to medieval lithologists, itinerant healers who specialized in surgical removal of bladder stones. Association meeting and physicians are now starting to use our In-Tac system. With this 510k approval, we will be launching our In-Fast system at the American College of Obstetricians and Gynecologists The American College of Obstetricians and Gynecologists (ACOG) is a professional association of medical doctors specializing in obstetrics and gynecology in the United States. It has a membership of over 49,000[1] and represents 90 percent of U.S. meeting this week." Influence was founded in 1994 as a technology company dedicated to providing innovative solutions for incontinence management to the estimated 50 million persons worldwide afflicted af·flict tr.v. af·flict·ed, af·flict·ing, af·flicts To inflict grievous physical or mental suffering on. [Middle English afflighten, from afflight, with the disorder. With offices in the U.S., Israel, Germany and the U.K., the company intends to develop and market a complete disease management system of products for the diagnosis and treatment of urinary incontinence in both women and men. In-Tac and In-Fast represent the first two of Influence's family of therapeutic and diagnostic products to be granted FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval. -0- This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results or events to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, without limitation, the unpredictability of market acceptance, likelihood of additional FDA approvals, safety, practicality and efficacy of the products mentioned in this release. CONTACT: Influence Inc. John Harland, 415/421-5600 www.influencemedical.com |
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