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Radiofrequency Energy Safe And Effective For Treatment Of Sleep Apnea SUNNYVALE, CA -- June 10, 1999 -- Somnus Medical Technologies, Inc., today announced the publication of a pivotal study in the May issue of the medical journal Otolaryngology -- Head and Neck Surgery reporting that physicians can successfully use radiofrequency (RF) energy to reduce the volume of the tongue, one of the primary contributors to obstructive sleep apnea (OSA). The study concluded that patients who received RF treatment delivered by the Somnoplasty(TM) System experienced more than a 50 percent reduction in their sleep interruptions and a decrease in daytime sleepiness. This is the first publication of this data, which had previously been presented at the American Academy of Otolaryngology -- Head and Neck Surgery Foundation annual meeting in September of 1998 and submitted to the U.S. Food and Drug Administration (FDA) last year. The Somnoplasty(SM) Procedure for OSA, a treatment that received FDA clearance in November 1998, is a minimally-invasive procedure that uses RF energy to reduce excess tissue at the base of tongue. During the procedure, the physician administers local anesthesia and then positions an electrode in the base of the tongue that transmits low levels of RF energy to coagulate the tissue. Patients who undergo the Somnoplasty Procedure for OSA spend approximately 30 to 45 minutes in the doctor's office. The procedure can be performed on an outpatient basis and patients can return to their normal activities that day or the following day. OSA is caused when excess tissues in the upper airway (back of the mouth, throat and nose) obstruct the airflow, causing patients to suffer an apnea (stop breathing entirely) or a hypopnea (the partial interruption of airflow). Patients with OSA experience at least five apneas or hypopneas per hour, with each episode lasting at least 10 seconds. In severe cases, patients can suffer up to several hundred apneic episodes per night. OSA is associated with impaired daytime functioning, hypertension and cardiovascular disease and results in approximately 38,000 deaths annually in the United States. Patients in the Stanford study stopped breathing an average of 40 times an hour during sleep. Following a limited treatment protocol with the Somnoplasty procedure, patients' sleep interruptions improved more than 50 percent, to about 18 apnea episodes per hour. The 18 patients in the study, all with mild to severe sleep apnea, had an average 17 percent decrease in tongue volume after a series of treatments with Somnoplasty. This level of reduction is comparable with current surgical techniques, but significantly less painful and involves a shorter recovery period. "This is a breakthrough in the treatment of sleep apnea," said Nelson Powell, MD, co-director of the Stanford University Sleep Disorders Center and author and primary investigator of the study. "We haven't had a new efficacious treatment with a scientific basis in years." The Somnoplasty System is currently being used to treat obstructive sleep apnea, chronic nasal obstruction and habitual snoring. During these procedures, the Somnoplasty System generates heat at temperatures between 60 degrees and 95 degrees Celsius to create finely-controlled coagulative lesions at precise locations within the upper airway. These lesions are naturally resorbed in approximately three to eight weeks, reducing excess tissue volume and opening the airway. A Somnoplasty Procedure, which is performed on an outpatient basis, typically takes 30 to 45 minutes, with only five to 10 minutes required for RF energy delivery. Some patients who undergo the Somnoplasty Procedure may experience swelling and minor discomfort. More than one treatment is usually necessary to achieve optimal results. E-mail this page to a friend or colleague! To print, use this version