FDA Clears New Device for Reducing Enlarged Tonsils

Somnus Medical Technologies Inc. (Sunnyvale, CA) has received FDA clearance for a new device designed to significantly reduce enlarged tonsils. The device was approved for use with the company's Somnoplasty system.

The Somnoplasty system uses a temperature-controlled radiofrequency-based technology, which heats a targeted area of obstructive tissue below the surface. The body naturally absorbs 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.

According to a recently published study conducted by Lionel M. Nelson, Somnus' director of medical affairs and an associate clinical professor in the Department of Surgery at Stanford University, the Somnoplasty procedure is a safe and effective method for treating enlarged tonsils in patients 18 years of age and older.

In the study, the procedure reduced tonsil size by a calculated average of 70% and increased airway size an average of 55%. The result was smaller tonsils, and the reduction of symptoms associated with upper airway obstruction such as snoring, daytime sleepiness, throat irritation, and speech and swallowing difficulties. Patients who participated in this study enjoyed a rapid recovery and few complications. Additional clinical research is planned to determine the effectiveness of the Tonsil Somnoplasty procedure in children up to the age of 18.

Edited by Ursula Jones