Respicardia, a US-based developer of implantable therapies, has announced the enrollment of the first patients in the pivotal trial to evaluate the remede system in patients with central sleep apnea (CSA).
The Respicardia pivotal trial is a randomized, controlled study designed to compare the use of the remede system with medical therapy to medical therapy alone. Patients will be enrolled at 25 centers in the US with additional centers in Europe.
The remede system is an implantable pacemaker-like device designed to stimulate the diaphragm to restore a more natural, less disrupted, breathing pattern.
Dr Rami Khayat enrolled the first patient at the Ohio State University Wexner Medical Center inColumbus, Ohio. Drs Andrew Kao of Mid America Heart Hospital in Kansas City, Missouri and Steven Krueger of Bryan Heart Hospital in Lincoln, Nebraska enrolled additional patients at their respective centers.
Dr Khayat said, "The remede system has the potential to offer an effective therapy for these patients using an implant, which requires no additional effort and is easily tolerated by the patient."
Dr Maria Rosa Costanzo, medical director of the Midwest Heart Specialists Heart Failure Program and the Edwards Center for Advanced Heart Failure in Naperville, Illinois, serves as international principal investigator.
The company will also present the pilot study results at the Heart Failure Society of America scientific sessions to be held in Orlando, Florida on 23 September, 2013.