The FDA has approved an investigational device exemption (IDE) for ImThera Medical’s THN3 Clinical Study, which will evaluate the safety and effectiveness of the aura6000 System for moderate to severe obstructive sleep apnea (OSA).
The device is intended to treat in individuals who are unable to comply or unwilling to try PAP therapy or other OSA treatments. Data from this clinical study will be used to support a Pre-Market Approval (PMA) application for the aura6000 System.
