www.fdanews.com/articles/183902-respicardias-sleep-apnea-device-receives-fda-approval
Respicardia's Sleep Apnea Device Receives FDA Approval
October 10, 2017
Respicardia won FDA approval for its Remedē System, a transvenous implantable neurostimulation system that engages the diaphragm to restore natural breathing during sleep in patients with central sleep apnea.
CSA disrupts the normal breathing pattern during sleep and negatively affects quality of life and overall cardiovascular health. CSA results from the brain's inability to send appropriate signals to the respiratory muscles to stimulate breathing.
Respicardia’s device creates negative pressure to move air into the lungs, similar to normal breathing. The system initiates therapy automatically and continues throughout the night without the need for a patient to apply any external equipment.