Dornier MedTech Gets FDA Approval For Treating Enlarged Prostates.KENNESAW, Ga.--(BUSINESS WIRE)--June 2, 1998-- Next Generation Device Offers More Convenience, Power Than Earlier Versions Dornier MedTech announced today it 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. clearance to market the UROWAVE, a microwave thermotherapy ther·mo·ther·a·py n. Medical therapy involving the application of heat. thermotherapy device used to treat 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. ). The UROWAVE, which offers significant advantages over similar therapy devices, allows non-surgical treatment of BPH to be performed on an outpatient basis. BPH, more commonly known as an enlarged prostate, occurs in half of men over age 50, and causes urinary problems, such as frequent urination urination Process of excreting urine from the bladder (see urinary system). Nerve centres in the spinal cord, brain stem, and cerebral cortex control it through involuntary and voluntary muscles. The need to void is felt when the bladder holds 3. , urgent urination, a weak urine stream, incomplete emptying of the bladder, awakening to urinate urinate /uri·nate/ (u´ri-nat) to discharge urine. u·ri·nate v. To excrete urine. urinate to void urine. , pain or burning sensations during urination and urinary tract infections. The UROWAVE is a compact and portable unit that allows for convenient use in any outpatient setting. It also delivers an industry-leading 90 watts of power to the tissue, more than any other product on the market. The UROWAVE offers fully automated software to allow ease of use, and is designed with an innovative urethral urethral pertaining to or emanating from urethra. urethral agenesis, urethral atresia failure of development of all or part of the urethra: characterized by complete urine retention. A rare cause of neonatal uremia. therapy probe, which allows full 360-degree cooling. "Physicians have come to expect only the best in urology products from Dornier," said Brian Walsh, Director of Marketing, Dornier Medical Systems, Inc. "Like all our products, the UROWAVE is backed by stringent research and our world-class service commitment." Clinical results for the UROWAVE show that 72 percent of treated patients experienced a reduction in symptoms, and treatment-related side effects were transient and not clinically significant. "The approval of the UROWAVE gives us a substantial addition to our product portfolio," said Walsh. "Now, patients will have the benefit of this out-patient treatment, and physicians have the confidence of knowing they're using a Dornier device. As we continue to expand our product offerings into the minimally invasive market, we are becoming the provider of choice for every urologic need." "We are very excited about UROWAVE thermotherapy as an innovative alternative for management of benign enlargement of the prostate," said Dr. Glen Preminger, a urologist at Duke University Medical Center who participated in the trial studies. "We believe this outpatient-based therapy offers a significant advantage over standard drug therapy and avoids the pain and risks associated with surgery, yet is highly effective in relieving the symptoms of BPH." Dornier pioneered the development of extracorporeal shock wave lithotripsy ESWL (Extracorporeal shock wave lithotripsy) The use of focused shock waves, generated outside the body, to fragment kidney stones. Mentioned in: Lithotripsy (ESWL ESWL (Extracorporeal shock wave lithotripsy) The use of focused shock waves, generated outside the body, to fragment kidney stones. Mentioned in: Lithotripsy ) 20 years ago and maintains its commitment to the industry by continuing to meet market demands. Based in Kennesaw, Georgia, Dornier Medical Systems has facilities across North America. Its Munich-based parent company, Dornier MedTech Holding International, is a member of the Singapore Technologies group, a technology-based conglomerate headquartered in Singapore. CONTACT: Dornier Brian Walsh, 770/514-6138 or Hill and Knowlton Kristi Ledford, 800/800-6438 |
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