The regulatory approval was based on findings from the remede System pivotal trial, which demonstrated that transvenous neurostimulation with the remede 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 remede 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.
"We are thrilled the remede System received FDA approval and are excited to provide this safe and effective therapy that is proven to improve the quality of life for CSA patients," said Bonnie Labosky, President and CEO of Respicardia.
"This is a significant step forward in our efforts to offer clinicians a breakthrough and effective treatment option for their patients with CSA."
Current treatment options are limited and there is a large unmet need. The remede 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 remede System experienced outstanding results and significant reduction in their CSA symptoms," said Maria Rosa Costanzo, MD, Principal Investigator of the remede 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."
In the remede System pivotal trial, 96% of patients were highly satisfied with their therapy. The company plans on an initial limited release that will progress to broader market commercialization.
The remede System Pivotal Trial, a prospective, multicenter, randomized controlled trial, evaluated the safety and effectiveness of transvenous phrenic nerve stimulation using the remede System in patients with moderate to severe CSA.
The primary effectiveness outcome was a comparison of the proportion of patients in the treatment versus control groups achieving a reduction in apnea-hypopnea index (AHI) of 50 percent or greater from baseline to 6 months. Clinical investigators at 31 sites in the United States and Europe implanted the remede System in 151 patients and randomized them 1:1 to the treatment or control group.
The trial met its primary endpoint for efficacy. In the modified intention-to-treat population, significantly more patients in the treatment group achieved 50 percent or greater reduction in AHI from baseline to 6 months than those in the control group with a clinically meaningful difference of 41% (p<0.0001).
Additionally, the 12-month freedom from serious adverse events related to the implant procedure, remede System or delivered therapy was 91 percent.
