Mentor Receives FDA Approval for Ultrasound-Assisted Lipoplasty.Business Editors/Health & Medical Writers SANTA BARBARA Santa Barbara (săn'tə bär`brə, –bərə), city (1990 pop. 85,571), seat of Santa Barbara co., S Calif., on the Pacific Ocean; inc. 1850. , Calif.--(BW HealthWire)--Oct. 17, 2001 Mentor Corporation (Nasdaq:MNTR) announced today that the Food and Drug Administration (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. ) has approved the marketing of Mentor's Contour Genesis System for ultrasound-assisted lipoplasty. Lipoplasty is a surgical procedure for removing subcutaneous fatty deposits for cosmetic purposes. It is the most frequently performed cosmetic surgical procedure in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . Ultrasound-assisted lipoplasty (UAL UAL United Airlines (ICAO code) UAL Unified Accelerator Library (Brookhaven National Laboratory) UAL User Account Lockdown UAL User Access Layer UAL Universal Auxiliary Language UAL User Agent Layer ) is an elective technique that has been used successfully to achieve a more aesthetically pleasing body appearance. The Contour Genesis System is indicated for the liquification and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery reconstructive surgery n. Plastic surgery. reconstructive surgery, n surgery to rebuild a structure for functional or esthetic reasons. , and Gynecological Surgery Gynecological surgery refers to surgery on a female's genital parts. This includes hymenoplasty and labiaplasty. Usually it is for reconstructive reasons. It can also be for aesthetic or sexual reasons. There could be tightening of the vaginal wall or making the entrance smaller. applications. It is also indicated for the liquification and aspiration of localized subcutaneous fatty deposits for the purposes of aesthetic body contouring. Mentor's Contour Genesis is the only surgical system that has received FDA approval for the specific indication of aesthetic body contouring. The Contour Genesis System was approved following a clinical study that included a total of 366 patients. There were 73 males and 293 females, ranging in age from 18 to 68. The use of Contour Genesis ultrasound-assisted lipoplasty resulted in improved body contour measurements and in high patient satisfaction as measured by Quality of Life questionnaires. Dr. William Adams, Assistant Professor of Plastic Surgery at the University of Texas Southwestern Medical School Ranking and selectivity The medical school ranked 19th in the 2008 U.S. News and World Report ranking of the top medical schools in the research category (ranked 6th among public medical schools), ranked 18th in primary care category, and ranked 21st in terms of research , was the medical director for the Contour Genesis clinical study. "The FDA approval for the Mentor UAL system is a landmark event in plastic surgery, as it marks the first FDA approval of any ultrasound device for body contouring," said Dr. Adams. "The findings and ultimate approval of the FDA validate the safety and efficacy of the Mentor UAL system that we have seen clinically in our practices over the past four years." Christopher J. Conway, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Mentor, said "The Contour Genesis represents a significant advance in the technology available to plastic surgeons. Mentor is committed to the growth of the plastic surgery field through the introduction of practice enhancing products such as this." Information about Mentor products can be found on the company's website, www.mentorcorp.com. Mentor Corporation develops and manufactures specialized medical products, which it markets throughout the world. This release contains, in addition to historical information, forward-looking statements. Such statements are based on management's current expectations and are subject to a number of uncertainties and risks that could cause actual results to differ materially from those described in the forward-looking statements. Factors that may cause such a difference include, but are not limited to, those described in the Company's Annual Report 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. for the fiscal year ended March 31, 2001. |
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