FDA clears Prostatron for mobile use.CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 4, 1996--EDAP Technomed, Inc. announced today that the U.S. 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 its application for mobile usage of the Prostatron(R). In May 1996 the FDA approved the Prostatron for treatment of symptomatic 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. (BPH BPH abbr. benign prostatic hyperplasia BPH Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men. ) or enlarged prostate. It took the FDA less than three months to evaluate and approve the application for Prostent mobile service. In a mobile configuration, the Prostatron is installed in a trailer and transported from one hospital to the other. Hospitals can contract to have the services available to their patients on a rotating basis. This set up allows hospitals to provide the latest medical therapy, cost-effectively. In many instances, it provides a trial run to insure that they have the patient populations prior to committing to an actual purchase of the machine. "Many of our currently installed sites have waiting-lists in excess of 300 patients," indicated Eric Poincelet, Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. of EDAP Technomed, Inc. "Providing mobile opportunities for the Prostatron will give thousands of patients easier access to this breakthrough technology." BPH affects 9 million men over the age of 50 throughout the United States alone. The Prostatron uses microwave energy or TransUrethral Microwave Thermotherapy (TUMT TUMT Transurethral microwave therapy, see there )(R) to provide long-term relief from the symptoms of BPH. The one-hour outpatient procedure requires only local anesthesia, and has virtually none of the risks or financial cost of surgical procedures. Patients can resume normal activities immediately following treatment. Due to strong patient demand, large institutions and university hospitals have been the first to acquire the Prostatron. Many leading centers such as Georgetown University Medical Center Georgetown University Medical Center (GUMC) is the medical campus at Georgetown University. It is co-located with Georgetown University Hospital on the University's main campus in Washington, DC. in Washington, DC, Long Island Jewish Hospital in New Hyde Park New Hyde Park, village (1990 pop. 9,728), Nassau co., SE N.Y., on Long Island; inc. 1927. It is a residential community with some manufacturing and truck farms. Nearby is the uninc. town of North New Hyde Park (1990 pop. 14,359). , NY, and Mt. Sinai Medical Center in Miami, Florida are already equipped, and attracting patients from far beyond their geographic region. Thomas Jefferson University It began as Jefferson Medical College in 1824. On July 1, 1969 the institution officially became Thomas Jefferson University. The university is made up of three colleges:
To accommodate patient and physician requests for information, a toll-free number, 1-800-933-TUMT, has been established. Additional information can be at obtained www.edaptechnomed.com. -0- EDAP Technomed is an international company which is engaged in the development, manufacture and distribution of minimally invasive therapeutic devices for the treatment of urological diseases including kidney stone disease, BPH and cancer. EDAP Technomed, Inc. based in Cambridge, Mass., is the US distributor of the Prostatron. CONTACT: EDAP Technomed, Inc. Elizabeth DiNolfo, 617/441-9212 edaptech@tiac.net www.edaptechnomed.com |
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