Respicardia has received US Food and Drug Administration (FDA) approval of its remedē system, a transvenous implantable neurostimulation device that stimulates the phrenic nerve and engages the diaphragm to restore natural breathing during sleep in patients with central sleep apnoea (CSA).
The regulatory approval was based on findings from the remedē system pivotal trial, which demonstrated that transvenous neurostimulation with the remedē system can significantly reduce the severity of CSA, improve sleep, quality of life and patient satisfaction. The data from the pivotal trial were published in The Lancet in September 2016.
The remedē system is indicated for the treatment of moderate to severe CSA in adult patients. CSA is a serious breathing disorder that 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. The condition has been associated with higher risks of atrial fibrillation (AF).
Current treatment options are limited and there is a large unmet need. The remedē system’s novel approach to treating CSA is a physiologic treatment that 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.
“The patients at our center treated with the remedē system experienced outstanding results and significant reduction in their CSA symptoms,” said Maria Rosa Costanzo, principal investigator of the remedē system pivotal trial. “Having a therapeutic option for patients with CSA that automatically provides therapy and works throughout the night is a breakthrough treatment for this serious breathing disorder.”