FDA Clears American Medical Systems' New Prolapse Repair System; Apogee Minimally Invasive Vaginal Vault Repair System Expands Women's Health Portfolio.Business Editors/Health/Medical Writers MINNEAPOLIS--(BUSINESS WIRE)--May 9, 2004 American Medical Systems Holdings Inc. (Nasdaq:AMMD AMMD Aerodynamic Mass Median Diameter ) announced today that its Apogee System received 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. clearance. The company also announced it will begin physician training in preparation for commercial release later this year. Apogee is a minimally invasive system designed for repairing vaginal vault prolapse prolapse Protrusion of an internal organ out of its normal place, usually of the rectum or uterus outside the body when supporting muscles weaken. The membrane lining the rectum can push out through the anus, most often in old people with constipation who strain during using the IntePro or InteXen graft material. Apogee joins the Straight-In Sacral sacral /sa·cral/ (sa´kral) pertaining to the sacrum. sa·cral adj. In the region of or relating to the sacrum. sacral, adj pertaining to the sacrum. Colpopexy System, AMS' current prolapse product, enhancing AMS' portfolio of products that treat pelvic floor defects in women. The company further announced the completion of the first procedure using the Apogee system by G. Willy Davila, M.D., a urogynecologist and Chairman of the Department of Gynecology at Cleveland Clinic Florida. Dr. Davila said, "For my patients with significant prolapse, the Apogee system offers a fast and simple technique that is important to successfully restore vaginal apical apical /ap·i·cal/ (ap´i-k'l) pertaining to an apex. a·pi·cal adj. 1. Relating to the apex of a pyramidal or pointed structure. 2. support and normalize normalize to convert a set of data by, for example, converting them to logarithms or reciprocals so that their previous non-normal distribution is converted to a normal one. anatomy. I am very excited to have Apogee as a new treatment for my prolapse patients." Douglas W. Kohrs, Chairman and Chief Executive Officer of American Medical Systems, said, "Apogee is a tremendous addition to our women's health Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. product portfolio. This is the first in a series of premium prolapse products designed to improve patient outcomes and reduce operating room operating room n. Abbr. OR A room equipped for performing surgical operations. time." Vaginal prolapse, a widespread problem among women, can be caused by pregnancy, vaginal delivery, and obesity. This quality of life issue for women becomes more prevalent with age. Over thirty-six million women in the U.S. and Europe suffer from prolapse, with over six million of those cases being severe. Current prolapse repair procedures are complex and lengthy, with only 350,000 patients surgically treated each year. The Apogee system offers a simpler, minimally invasive approach which is designed to deliver better outcomes than traditional abdominal or laparoscopic Laparoscopic A minimally-invasive surgical or diagnostic procedure that uses a flexible endoscope (laparoscope) to view and operate on structures in the abdomen. Mentioned in: Obstetrical Emergencies techniques. Approximately 40 percent of women treated for incontinence are treated for prolapse at the same time. Physicians can now combine Apogee with the company's urinary incontinence products, thus providing patients with complete, comprehensive repairs. American Medical Systems American Medical Systems, headquartered in Minnetonka, Minnesota, is the world leader in medical devices and procedures to cure incontinence, abnormal uterine bleeding, erectile dysfunction and urinary obstructions caused primarily by benign prostatic hyperplasia benign prostatic hyperplasia n. Abbr. BPH A nonmalignant enlargement of the prostate gland commonly occurring in men after the age of 50, and sometimes leading to compression of the urethra and obstruction of the flow of urine. or strictures. Although not life threatening, these disorders can significantly diminish one's quality of life and profoundly affect social relationships. In recent years the number of people seeking treatment has increased markedly as a result of longer lives, higher quality-of-life expectations and greater awareness of new treatment alternatives. Forward-Looking Statements. Statements about the company's future product availability and sales are forward-looking statements subject to risks and uncertainties including the timing and success of new product introductions, Physician acceptance, endorsement, and use of the company's products, competitor activities, changes in reimbursement rates, and potential product recalls. These risks and others are more fully described in the company's Annual Report on Form 10-K for the year ended January 3, 2004, and its other SEC filings. Actual results may differ materially from anticipated results. More information about the company and its products can be found at its website www.AmericanMedicalSystems.com. Apogee, IntePro, InteXen, and Straight-In are trademarks of American Medical Systems or its subsidiaries. |
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