Mentor Receives FDA Approval for New NovaSilk Synthetic Mesh Product Used in the Treatment of Pelvic Organ Prolapse.SANTA BARBARA, Calif. -- Mentor Corporation (NYSE NYSE See: New York Stock Exchange :MNT See molecular nanotechnology. ), a leading supplier of medical products in the United States and internationally, today announced that it has received U.S. Food and Drug Administration approval to begin marketing its new NovaSilk(TM) synthetic mesh product used in the treatment of pelvic organ 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 in the United States. "Treating prolapse with grafts and synthetic mesh is increasingly being adopted by the physician community, as more clinical data indicates higher failure rates for previous (tissue plication plication /pli·ca·tion/ (pli-ka´shun) the operation of taking tucks in a structure to shorten it. Kelly plication ) procedures. NovaSilk is a very nice addition to Mentor's product portfolio and offers a macroporous, knitted, monofilament monofilament, n a single strand of untwisted synthetic material such as nylon; used to create surgical sutures. monofilament polypropylene mesh, while also being soft and light," said Edward J. Stanford, MD, FACS FACS Fellow of the American College of Surgeons. FACS abbr. Fellow of the American College of Surgeons FACS fluorescence-activated cell sorter. . Pelvic organ prolapse occurs when the pelvic floor muscles become weak or damaged and can no longer support the pelvic organs Pelvic organs The organs inside of the body that are located within the confines of the pelvis. This includes the bladder and rectum in both sexes and the uterus, ovaries, and fallopian tubes in females. Mentioned in: Appendectomy . The condition is estimated to afflict as many as 40% of women over the age of 50 years, representing approximately 36 million women in the U.S. and Europe. While prolapse is not considered a life threatening condition, it may cause a great deal of discomfort, distress and embarrassment. The use of synthetic meshes for the treatment of pelvic organ prolapse represents one of the fastest growing segments of the 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. market. "The addition of NovaSilk to Mentor's expanding portfolio of women's health products for pelvic organ prolapse or stress urinary incontinence stress urinary incontinence n. See stress incontinence. reinforces the commitment of our urology franchise to surgeons and the patients they serve by providing high quality product offerings and customer service and support," commented Joshua H. Levine, President and Chief Executive Officer of Mentor Corporation. NovaSilk is a soft and lightweight mesh comprised of a knitted, monofilament polypropylene. NovaSilk is Mentor's first synthetic mesh product for the treatment of pelvic organ prolapse. The Company also markets its human tissue-based Axis(TM) and Suspend(TM) products for the treatment of pelvic organ prolapse. About NovaSilk(TM) NovaSilk(TM) is a soft and lightweight mesh that is comprised of a knitted, monofilament polypropylene. NovaSilk offers resistance to traction, allows tissue colonization and facilitates positioning during surgery. It can be used for a variety of pelvic floor procedures, including cystocele, enterocele, rectocele rectocele /rec·to·cele/ (rek´to-sel) hernial protrusion of part of the rectum into the vagina. rec·to·cele n. See proctocele. and vaginal vault prolapse procedures. About Mentor Corporation Founded in 1969, Mentor Corporation is a leading supplier of medical products for the global healthcare market. The Company develops, manufactures and markets innovative, science-based products for the aesthetics, urologic specialties and clinical and consumer healthcare markets around the world. The Company's website is www.mentorcorp.com. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement All statements included or incorporated by reference in this release, other than statements or characterizations of historical fact, are forward-looking statements. These forward-looking statements are based on our current expectations, estimates and projections about our industry, management's beliefs and certain assumptions made by us. Forward-looking statements in this press release include but are not limited to those statements related to the fast growing segment of the women's health market. Forward-looking statements can also be identified by words such as "anticipates," "expects," "intends," "plans," "predicts," "believes," "seeks," "estimates," "may," "will," "should," "would," "could," "provide," "potential," "continue," similar expressions, and variations or negatives of these words. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements speak only as of the date hereof and are based upon the information available to us at this time. Such information is subject to change, and we will not necessarily inform you of such changes. These statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statement as a result of various factors. The Securities and Exchange Commission filings of Mentor, including, without limitation, its Annual Reports on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. , subsequent quarterly reports on Form 10-Q, and recent Current Reports on Form 8-K, discuss important risk factors that could contribute to such differences or otherwise affect its business, results of operations and financial condition. Mentor undertakes no obligation to revise or update publicly any forward-looking statement for any reason. |
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