US-based Respicardia has unveiled six month results from the remede system pilot study, the first prospective, multi-center, global trial to treat central sleep apnea (CSA).
The remede system delivers electrical pulses to one of the body’s two phrenic nerves through an implantable lead and the diaphragm responds by restoring a more natural, less disrupted, breathing pattern.
A total of 44 central sleep apnea patients were implanted with the remede system, designed to restore normal sleep and breathing to improve respiratory and cardiovascular health in CSA patients, and completed six months of follow-up in the multi-center global trial.
The study results showed more than 50% reduction in patients’ apnea-hypopnea index, 50% improved oxygenation, decreased arousals and improved quality of life.
Co-principal investigator of the remede System pilot study Dr William Abraham said: "The remede System which provides a safe and innovative therapy shows promise for the treatment of CSA and is being studied further in the pivotal trial."
Respicardia president and CEO Bonnie Labosky noted the company is pleased with the six month results from the pilot study.
"These findings reaffirm our belief that the remede System will improve patients’ quality of life and will become a standard of care for treating Central Sleep Apnea," Labosky added.