FDA Clears Device for Treatment of Obstructive Sleep Apnea

Somnus Medical Technologies Inc. announced FDA clearance of its Somnoplasty System for the treatment of obstructive sleep apnea. The procedure treats sleep apnea by shrinking soft tissue in the upper airway including the base of tongue.

The Somnoplasty system has already been cleared by FDA for use in the treatment of habitual snoring and chronic nasal obstruction. The procedure for obstructive sleep apnea offers patients and physicians an alternative to the current treatment regimen of highly invasive surgery or the nightly use of forced air ventilation therapy.

The system uses RF energy to provide a minimally invasive treatment of upper airway obstructions under local anesthesia. Heat is generated to create finely controlled coagulative lesions at precise locations within the upper airway including base of tongue. The lesions created by the procedure are naturally resorbed in approximately three to eight weeks, reducing excess tissue volume and opening the airway.