Updated February 24, 2014, with details from Inspire Medical.
An expert panel of FDA advisors voted today to recommend approval for Inspire Medical’s sleep apnea implant, the Inspire II Upper Airway Stimulator, the company confirmed.
The agency’s Anesthesiology & Respiratory Therapy Devices Panel voted unanimously in favor of approving the device, which uses electrical stimulation to keep airways open during sleep. The implant stimulates the hypoglossal nerve, preventing the tongue from obstructing breathing.
Panelists voted unanimously with 1 abstention that the device is safe, that it is effective and that its benefits outweigh its risks, Inspire Medical Business manager Heather Gilbert told MassDevice.com.
In materials released ahead of the panel review, FDA regulators highlighted concerns with non-serious adverse events such as tongue soreness, irritation and abrasion, mouth dryness, mechanical pain and discomfort associated with long-term use of electrical stimulation. The advisors further examined the durability of the therapy, proper screening methods, post-approval study protocols and other aspects of the technology.
The FDA considers the recommendations of its expert advisory panels, but is not required to abide by their rulings. FDA regulators will have the final say in whether Inspire Medical receives premarket approval, but the agency frequently agrees with its panels.
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