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| |  Radiofrequency Therapy Improves Breathing In All Patients With Chronic Nasal Obstruction SUNNYVALE, CA -- June 10, 1999 -- Sufferers of chronic nasal obstruction, people whose constant congestion forces them to breathe out of their mouths and hinders the simple acts of sleeping, eating and breathing, have promising news today about a treatment that may alleviate their symptoms. According to a Stanford University School of Medicine and V.A. Palo Alto Health Care System study published in the May issue of Laryngoscope, chronic nasal obstruction patients breathed more freely after receiving treatment with Somnus Medical Technologies, Inc.’s Somnoplasty(TM) System. The study shows that patients whose nasal passages were uncomfortably blocked by swollen tissues (enlarged inferior turbinates) experienced significant improvement of nasal obstruction after a single treatment. The results of the study, which was conducted by Stanford physicians David Utley, M.D. and Richard Goode, M.D., demonstrate that the majority of patients who were previously dependent on nasal sprays to treat congestion were able to discontinue use of the medication after the Somnoplasty procedure. The procedure caused little pain among patient participants and no patients experienced bleeding or significant crusting, or required prescription pain medication following treatment. "There was a statistically significant improvement in the size of the obstructing nasal tissues after treatment," Dr. Utley said. "The patients reported no significant discomfort and all patients had improvement in nasal breathing. Additionally, most of the patients in this study previously relied on nasal medications to relieve their symptoms but two months after treatment, 89 percent of these patients were no longer using their nasal medication." Chronic nasal obstruction is a symptom of chronic rhinitis -- a condition that affects an estimated 50 million Americans. Nasal obstruction is most typically caused by enlargement of the inferior nasal turbinates -- small, shelf-like structures within the nose. Normally, turbinates swell and contract to warm and humidify air as it is inhaled. Chronic turbinate enlargement can impair normal breathing, force patients to breathe through the mouth and turn the simple acts of eating, drinking and speaking into annoying and sometimes uncomfortable experiences. It can also contribute to symptoms such as sleeplessness, fatigue and headaches. The Stanford study was conducted on 10 patients with nasal obstruction caused by enlarged inferior turbinates. During the study, each patient was treated with a proprietary radiofrequency technology that included an RF control unit and a single-use disposable, surgical handpiece developed by Somnus Medical Technologies, Inc. During the procedure, a needle electrode delivered RF energy to two sites in each inferior turbinate, for a total treatment time of approximately two minutes for each nostril. Patients in the study were evaluated at one and eight weeks following treatment. At each visit, the degree of nasal obstruction was graded by both the primary surgeon and the patient. After eight weeks, all 10 patients demonstrated subjective improvement and eight of the nine patients who previously depended on nasal medications such as prescription decongestants or over-the-counter drugs, had discontinued use. These findings further substantiate the results of an earlier study that addressed the safety and efficacy of RF in the upper airway. This study by Kasey Li, M.D. and colleagues from the Stanford Center of Excellence for Sleep Disorders, evaluated the use of radiofrequency energy to treat chronic nasal obstruction. The study showed that patients treated with the Somnoplasty procedure experienced an overall improvement in their breathing. The Somnoplasty System is currently being used to treat chronic nasal obstruction, obstructive sleep apnea 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. More than one treatment may be necessary to achieve optimal results, depending on the procedure.
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