American Medical Systems Announces FDA Clearance For Elevate(R) Anterior And Apical Prolapse Repair System

Main Category: Sexual Health / STDs
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 12 Jan 2009 - 3:00 PST

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American Medical Systems, Inc., (AMS) (NASDAQ: AMMD) announced FDA clearance of its Elevate Anterior Prolapse Repair System. This latest addition to the AMS product line, along with the successful launch of Elevate Posterior Prolapse Repair System in 2008, provides a comprehensive solution for treating all types of prolapse. The condition affects more than 30 million women in the United States and is caused when one or more female pelvic organs protrude or herniate into the vaginal wall, which often causes pain, discomfort and other symptoms.

Designed with safety in mind, Elevate Anterior Prolapse Repair System is a minimally invasive, single-incision total transvaginal approach for treating cystoceles and vault prolapse. It utilizes minimal blind needle passages and follows proven implant pathways. Elevate's design incorporates low profile self-fixating tips to secure the graft and repair the defect. The absence of external skin incisions and Elevate's low profile tips minimize tissue trauma, which provides the potential for enhanced patient recovery.

"We are pleased to offer this new product for the treatment of prolapse which further enhances the AMS portfolio of pelvic health solutions for women," says John Nealon, senior vice president and general manager of women's health at American Medical Systems. "Consistent with AMS' philosophy to support all of its products with clinical data, the Elevate Anterior System is currently in clinical studies. A limited launch in the first half of 2009 with a full commercial launch by the third quarter of 2009 is planned."

About American Medical Systems

American Medical Systems, headquartered in Minnetonka, Minn., is a diversified supplier of medical devices and procedures to cure erectile dysfunction, benign prostate hyperplasia, incontinence, menorrhagia, prolapse and other pelvic disorders in men and women. 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. American Medical Systems' products reduce or eliminate the incapacitating effects of these diseases, often through minimally invasive therapies. The Company's products were used to treat approximately 310,000 patients in 2007.

More information about the Company and its products can be found at its website http://www.AmericanMedicalSystems.com and in the Company's Annual Report on Form 10-K for 2007 and its other SEC filings.

American Medical Systems