The Food and Drug Administration (FDA) has approved the Remedē® System (Respicardia, Inc.), a new device indicated for the treatment of moderate to severe central sleep apnea.
Individuals with central sleep apnea may stop breathing during sleep for ≥10 seconds due to the brain failing to signal the diaphragm to breathe. Some treatment options for moderate to severe sleep apnea include positive airway pressure devices (eg, continuous positive airway pressure machine), drug therapy, or surgery.
The implantable device works by stimulating a nerve in the chest that is involved in transmitting signals to the diaphragm to stimulate breathing. The Remedē System consists of a battery pack that is implanted under the skin in the upper chest area; thin wires are inserted into the blood vessels in the chest near the phrenic nerve that stimulates breathing. During sleep, the patient’s respiratory signals are monitored and the system stimulates the nerve to move the diaphragm for normal breathing.
The efficacy of the Remedē System was based on a study2 of 141 patients (Respicardia, Inc. Pivotal Trial of the Remedē System; ClinicalTrials.gov Identifier NCT01816776); the study evaluated the effectiveness of the system in reducing the apnea-hypopnea index (AHI). The AHI is a measure of the frequency and severity of apnea episodes. At 6 months, 51% of patients with the Remedē System implant experienced a ≥50% reduction in AHI. Patients without the implant experienced an 11% reduction in AHI.
Device interaction, implant site infection, swelling and local tissue damage, and pocket erosion were the most frequent adverse effects reported. The Remedē System should not be used in patients with an active infection or in those who require magnetic resonance imaging. Moreover, the device is not intended for patients with obstructive sleep apnea.
- Respicardia’s remedē® System receives FDA approval [news release]. Minnetonka, MN: Respicardia, Inc. http://www.respicardia.com/respicardias-remede-system-receives-fda-approval/. Published October 10, 2017. Accessed October 19, 2017.
- Costanzo MR, Ponikowski P, Javaheri S, et al; for the Remedē System Pivotal Trial Study Group. Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial. Lancet. 2016;388(10048):974-982.
This article originally appeared on MPR