aura6000™ system

Approval order statement

Approval for the aura6000™ system, which includes the Implantable Pulse Generator Model #100.0100, Lead Models #300.0100 (25cm) and #300.0200 (33cm), Remote Control & Charger Model #500.0100, Charging Antenna Model #500.0300, aura Clinical Manager Model #700.0100, Torque Wrench, and Suture Sleeve. The device is indicated for the reduction of apneas, hypopneas, or both in adult patients with moderate to severe obstructive sleep apnea (OSA), defined as an apnea-hypopnea index (AHI) of = 15 and = 65. The aura6000™ system is intended for patients who failed, do not tolerate, or are ineligible to be treated with current standard of care treatments such as positive airway pressure (PAP), oral appliances (e.g. mandibular advancement device), or pharmacotherapy. PAP failure is defined as an inability to eliminate OSA (AHI of greater than 15 despite PAP usage), and PAP intolerance is defined as:• Inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night), or• Unwillingness to use PAP (e.g., a patient returns the PAP system after attempting to use it).