Study: Implants reduced sleep apnea in 81% of participants
SAINT PAUL, Minn. - A one-year clinical study showed that Restore Medical's palatal implants reduced sleep apnea in 81% of 26 participants, the company stated in a release last week.
The procedure, which was cleared by the FDA in August 2004, involves placing three small inserts in the patient's soft palate, causing the palate to stiffen. Sleep apnea occurs when air can't flow freely through the airway, often due to a soft palate.
Restore offers its Pillar Procedure as an alternative to CPAPs. Multiple published studies show that patient compliance with CPAP therapy can be as low as 50% due to the general discomfort and inconvenience of wearing a mask to bed every night, according to the company.
The study, "Long-Term Follow-up of Palatal Implants for Treatment of Obstructive Sleep Apnea," also showed resolution of sleep apnea in 60% of participants, as measured by their Apnea Hypopnea Index. The study was conducted in Europe.
The results were presented at the 109th American Academy of Otolaryngology-Head and Neck Surgery Annual Meeting in Los Angeles in late September.