Important Safety Information About the Pillar Procedure
The Pillar® Procedure is indicated for use in a) the reduction of symptomatic, habitual, or social snoring caused by a flutter of tissue in the soft palate, and/or b) upper airway obstruction in patients with mild to moderate obstructive sleep apnea (OSA). The Pillar Procedure is a minimally invasive polyester implant that is used to stiffen the soft palate tissue to reduce the flutter that causes snoring and/or palatal obstruction of the upper airway.
Since the Pillar Procedure does not involve removing or destroying tissue, the risk of complication is extremely low. There have been no reported major adverse events as a result of the Pillar Procedure. With more than 45,000 Pillar Procedures performed worldwide, the reported complication rate is less than 1%.
The most frequently reported minor complication is a partial extrusion of an implant. A partial extrusion occurs when the implant is placed too shallow or too deep, and the tip of the implant protrudes through the surface of the soft palate tissue. If a partial extrusion occurs, the physician can remove the implant.
This therapy is not for everyone. Please consult an ear, nose, and throat (ENT) doctor or other Pillar Procedure specialist to determine if you are a candidate. This procedure must be performed by a qualified physician.
Attention Physicians: For further information, please call Medtronic at 800-874-5797 or consult the Medtronic website at http://www.medtronicsleep.com.
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