American Medical Systems Announces FDA Clearance of Minimally Invasive Treatment for Bladder Prolapse.Business Editors/Health/Medical Writers MINNEAPOLIS--(BUSINESS WIRE)--May 24, 2004 Innovative Perigee Cystocele Repair System Further Expands 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. Portfolio American Medical Systems Holdings, Inc. (Nasdaq:AMMD AMMD Aerodynamic Mass Median Diameter ) announced today its Perigee Cystocele Repair 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. 510(k) clearance. The company also announced it will begin physician training on this system in preparation for commercial release later this year. Perigee is the latest in a series of products American Medical Systems has developed to repair pelvic floor defects in women, joining the Apogee Vaginal Vault System, 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, IntePro Polypropelene Mesh and InteXen Porcine porcine /por·cine/ (por´sin) pertaining to swine. porcine pertaining to pig. See also hog (1), swine. porcine circovirus 1 a nonpathogenic virus. Dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin. der·mal or der·mic adj. Of or relating to the skin or dermis. Matrix. With Perigee, helical needles are used to introduce a supportive mesh to correct for the bladder's herniation herniation /her·ni·a·tion/ (her?ne-a´shun) abnormal protrusion of an organ or other body structure through a defect or natural opening in a covering, membrane, muscle, or bone. through the vaginal wall. This minimally invasive surgical technique is designed to improve patient outcomes and reduce operating room time versus traditional bladder 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 repair techniques. Douglas W. Kohrs, Chairman and Chief Executive Officer of American Medical Systems, said, "With the addition of Perigee to our product line, American Medical Systems clearly has the most comprehensive offering of prolapse products in the world today. Perigee is truly a pioneering design, yet again reinforcing AMS' ability to bring significant improvements to the field of women's health." Kohrs continued, "We are excited to be able to leverage our unique needle technology to address bladder prolapse. Perigee is the first minimally invasive surgical system designed to repair bladder prolapse in women, and also provides the physician the flexibility to use either our IntePro or InteXen graft material." Pelvic organ prolapse, a widespread problem among women, can be caused by pregnancy, vaginal delivery, or 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 having severe cases. Current prolapse repair procedures often have poor outcomes, are complex and lengthy, and only 350,000 patients are surgically treated each year. The Perigee 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% of women treated for incontinence are treated for prolapse at the same time. Physicians will be able to combine Perigee with any one of AMS' five 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 and in the company's Annual Report on Form 10-K for 2003 and its other SEC filings. Perigee, Apogee, IntePro, InteXen and Straight-In are trademarks of American Medical Systems or its subsidiaries. NOTE TO EDITORS: In the product name InteXen noted in this news release, there is a macron ma·cron n. 1. A diacritical mark placed above a vowel to indicate a long sound or phonetic value in pronunciation, such as ( ) in the word make.2. over the second "e." This symbol may not appear properly in some systems. |
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) in the word make.
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