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CADTH » Search All Products » Environmental Scanning » Health Technology Update » Issue 1, Fall 2005 » New treatment for sleep apnea

New treatment for sleep apnea

A minimally invasive surgical treatment for obstructive sleep apnea is gaining the attention of ear, nose and throat specialists in the US.

The Pillar™ Palatal Implant System Photo courtesy of Restore Medical Inc

The Pillar™ Palatal Implant System

Photo courtesy of Restore Medical Inc.

Palatal implants are tiny, braided, polyester threads placed in the soft palate (at the back of the roof of the mouth) to reinforce and stiffen tissues that often flutter and obstruct the upper airway.

Obstructive sleep apnea and excessive snoring are the result of airway blockage when tissues at the back of the throat collapse and close during sleep, causing pauses in breathing or shallow breathing and poor sleep.

An estimated 4% of Canadian men and 2% of Canadian women have obstructive sleep apnea, with chronic daytime sleepiness.[1]

Sleep apnea is also associated with an increased risk of more severe health problems, such as high blood pressure, stroke, and heart attack.[2]

During the palatal implant procedure, three segments of thread are permanently embedded in the palate during an office visit. This is done under local anesthesia, using a small disposable delivery tool. The threads, which are 18.0 mm long and 1.5 mm in diameter, cannot be seen once they are in place. There is little pain associated with the procedure and most patients resume normal activities and diet the same day.[3]

Regulatory status

The Pillar™ Palatal Implant System received US Food and Drug Administration (FDA) approval in February 2004, for the treatment of patients with mild to moderate obstructive sleep apnea.[4,5]

John Foster, senior vice-president of commercial operations at implant manufacturer Restore Medical Inc., said that his company will decide in the next six to nine months when an approval application will go to Health Canada.

Cost

Mr. Foster reported that the procedure costs up to US$2,500, including US$750 for the set of three implants.

Evidence of effectiveness

In a small, non-randomized European clinical trial funded by Restore Medical, 46 non-obese adults with mild to moderate obstructive sleep apnea (defined as 10 to 30 episodes of upper airway obstruction per hour) received the palatal implants. Ninety days after the procedure, the number of apnea episodes was halved in more than 3/4 of patients. After treatment, 23 patients (50%) no longer met the criteria for mild to moderate obstructive sleep apnea, as the number of apnea episodes decreased to less than 10 per hour. Five patients did not have a significant decrease in apnea. Two patients had the implant removed after partial extrusion occurred. No serious adverse events were reported.[5] Further clinical trial results are expected to be published in 2005. No studies have compared the palatal implants with continuous positive airway pressure (CPAP), or to other treatments for sleep apnea.

References

[1] Lung Association. Sleep apnea action handbook. Ottawa: Lung Association; 2005. Available: http://www.lung.ca/sleepapnea/handbook/Sleep_Apnea_Action_Handbook.pdf.

[2] Flemons WW. N Engl J Med 2002;347(7):498-504.

[3] Nordgård S, et al. Acta Otolaryngol 2004;124(8):970-5.

[4] Center for Drug Evaluation and Research, U.S. Food and Drug Administration. 510(k) summary: Pillar Impant System (K040417). Rockville (MD): The Center; 2004. Available: http://www.fda.gov/cdrh/pdf4/k040417.pdf.

[5] Restore Medical. A new first-line treatment option for mild to moderate obstructive sleep apnea. St. Paul (MN): Restore Medical; 2004. Available: http://www.restoremedical.com/docs/Clinical_Summary_WP_approved091404.pdf.