The US Food and Drug Administration (FDA) has given investigational device exemption (IDE) approval to Apnex Medical’s clinical study to evaluate the safety and effectiveness of its Hypoglossal Nerve Stimulation (HGNS) System to treat obstructive sleep apnea (OSA).
The company will enroll patients who did not respond to continuous positive airway pressure (CPAP) or other OSA treatments in the multi-center, prospective, randomized study.
The study is being conducted in leading medical centers in the US, Europe and Australia.
The HGNS System is an implantable therapy that is intended to work by activating the muscles in the upper airway to ensure that the airway remains open during sleep.
The system detects the patient’s breathing and delivers mild stimulation to the hypoglossal nerve, which controls the muscles of the tongue, to keep the airway open.
The HGNS System is designed to work only when the patient is asleep through a handheld controller.
The company intends to submit the clinical study data to the FDA for pre-market approval (PMA).