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Somnus Announces New Device for Turbinate Somnoplasty®

Sunnyvale, CA - April 3, 2001

Somnus Medical Technologies, Inc. announced it has begun shipment of a new Turbinate Somnoplasty Device for the treatment of chronic nasal obstruction, or a stuffy nose, due to enlarged turbinates. The U.S. Food and Drug Administration (FDA) cleared the initial Turbinate Somnoplasty Device in 1997.

Enlarged turbinates and nasal congestion can impair normal breathing, force patients to breathe through the mouth and turn the simple acts of eating, drinking, and speaking into an annoying and sometimes painful experience. A chronic stuffy nose can also contribute to headaches and sleep disorders such as snoring and obstructive sleep apnea, as the nasal airway is the normal breathing route during sleep.

Those suffering from enlarged turbinates often endure the prolonged use of intranasal sprays and medication -- some carrying significant side effects. Over time, compliance and effectiveness of these medical therapies can be compromised. Historically, surgical intervention was the only permanent solution considered for only the most severely affected patients.

The Turbinate Somnoplasty Treatment is performed in an outpatient setting under local anesthesia. It takes less than two minutes per turbinate and avoids the pain and inconvenience associated with traditional techniques. Patients enjoy a speedy recovery and may avoid the long-term use of medications and nasal sprays.

The ergonomic design of the new turbinate handpiece allows for easy electrode placement. Its design provides physicians with the ability to reach all areas of the inferior turbinate. Its streamlined design allows for enhanced visualization.

"Physicians who have evaluated the new handpiece felt it enhanced their ability to effectively treat patients with chronically enlarged turbinates. It continues to provide the same excellent results-improved breathing and longer lasting relief from chronic nasal congestion," said John Schulte, Somnus President and Chief Executive Officer.

About the Somnoplasty System and Its Applications

Somnus is pioneering a new standard of care for the treatment of upper airway disorders. The Company's proprietary Somnoplasty System is the only temperature-controlled radiofrequency-based technology that has been previously cleared by the FDA for use in the treatment of chronic nasal obstruction and sleep disordered breathing-obstructive sleep apnea syndrome, upper airway resistance syndrome, habitual snoring, as well as a device for tissue coagulation in the head and neck. The Somnoplasty procedures work by heating a targeted area of obstructive tissue below the surface. The body naturally resorbs the heated area over a period of three to eight weeks reducing tissue volume. Clinical evaluations are underway to further expand the indications for the treatment of other upper airway obstructions.

 

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