FDA approves Remede System implanted device for treating moderate to severe central sleep apnea.- Respicardia.

The FDA approved the Remede System, from Respicardia, a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea. It is an implantable device that stimulates a nerve located in the chest that is responsible for sending signals to the diaphragm to stimulate breathing.

Approval is based on an evaluation of data from 141 patients to assess the effectiveness of the Remede 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 Remede System implanted. AHI was reduced by 11 percent in patients without an active Remede 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 Remede 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.

The Remede System is an implantable device that stimulates a nerve located in the chest that is responsible for sending signals to the diaphragm to stimulate breathing. It is comprised of a battery pack surgically placed under the skin in the upper chest area and small, thin wires that are inserted into the blood vessels in the chest near the nerve (phrenic) that stimulates breathing. The system monitors the patient's respiratory signals during sleep and stimulates the nerve to move the diaphragm and restore normal breathing.