Respicardia®, a developer of implantable therapies to improve respiratory and cardiovascular health, announced results from the remede System Pilot Study during the Heart Failure Society of America (HFSA) Late Breaking Scientific Session in Orlando. Dr. William T. Abraham of The Ohio State University Wexner Medical Center in Columbus presented the results for the first and only implantable device for respiratory rhythm management to treat central sleep apnea (CSA).
The remede System Pilot Study represents the first prospective, multi-center, global trial to treat CSA. Implanted by electrophysiologists using a procedure similar to the implantation of intracardiac devices, the remede System is designed to restore normal sleep and breathing to improve respiratory and cardiovascular health in patients with CSA. A total of 44 CSA patients were implanted with the system and completed 6 months of follow-up. Patients experienced a greater than 50% decrease in apnea-hypopnea index (AHI), improved oxygenation by over 50%, decreased arousals and improved quality of life.
"I am impressed by the clinically meaningful results of the remede System," says Dr. William Abraham, Co-Principal Investigator of the remede System Pilot Study. "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."
CSA is associated with increased mortality and hospitalization in heart failure (HF) patients. Studies show that CSA affects up to 40% of HF patients and 30% atrial fibrillation patients.
"We are pleased with the 6 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," remarked Bonnie Labosky, President and CEO of Respicardia.
Irregular sleep may elevate risk of major cardiovascular events