Cardiac Concepts, a developer of medical devices to treat heart failure patients who experience breathing disturbances during sleep, has reported the enrollment of the first European patients in a pilot clinical trial of the RespiCardia System.
Cardiac Concepts said that the purpose of the pilot study is to understand the respiratory and cardiac benefits of the RespiCardia System when treating a breathing disorder called central sleep apnea (CSA) in heart failure patients.
The RespiCardia System is an implantable device using small, electrical pulses designed to restore more natural breathing patterns in patients with sleep disordered breathing.
Ponikowski, professor and principal investigator of the pilot clinical trial at The Medical University/4th Military Hospital in Wroclaw, said: “We are excited to be the first in Europe to bring this new device to patients. We understand more about the link between Heart Failure and Central Sleep Apnea and there is an unmet clinical need for treating this group of patients.
“This technology has the potential to improve the quality of life and potentially the outcomes of those suffering from Heart Failure and Central Sleep Apnea.”
Bonnie Labosky, CEO of Cardiac Concepts, said: “We look forward to including other centers in our pilot study and providing physicians with new options to treat Central Sleep Apnea in Heart Failure patients.”