The FDA approved to market this product on October 6, 2017.
The remedē System delivers a small electrical stimulus to the phrenic nerve while a patient is asleep. This stimulus makes the diaphragm muscle contract, which causes the patient to take a breath. The remedē System has 2 modes – it can be set to generate pulses at a fixed rate (asynchronous therapy) or it can deliver a pulse only when it detects a pause in breathing (synchronous therapy). The physician is able to set the stimulator to deliver the most appropriate therapy for the patient. The system has safeguards to make sure that therapy is only delivered during sleep, for example it works only at the time of day when the patient is expected to be sleeping, and it turns on only when the patient is inactive and lying down.
The FDA evaluated data from 141 patients to assess the effectiveness of the Remedē System in reducing apnea hypopnea index (AHI), a measure of the frequency and severity of apnea episodes. After six months, AHI was reduced by 50 percent or more in 51 percent of patients with an active Remedē System implanted. AHI was reduced by 11 percent in patients without an active Remedē System implanted.The most common adverse events reported included concomitant device interaction, implant site infection, and swelling and local tissue damage or pocket erosion. The Remedē System should not be used by patients with an active infection or by patients who are known to require magnetic resonance imaging. This device is not intended for use in patients with obstructive sleep apnea, a condition in which the patient attempts to breathe, but the upper airway is partially or completely blocked.