First U.S. implant of RespiCardia System for treatment of sleep apnea

Cardiac Concepts, Inc. announced today the first U.S. clinical implant of the RespiCardia® System at The Ohio State University Medical Center, Columbus, Ohio.  The RespiCardia System is a fully implantable device that is designed to restore more natural breathing patterns in patients with central sleep apnea, a sleep disorder characterized by a lack of respiratory effort by the diaphragm.  The procedure was performed by Dr. Ralph Augostini, Assistant Professor of Clinical, Cardiovascular Medicine at The Ohio State University, on a 61 year old male patient with a history of central sleep apnea and atrial fibrillation.

This was the first U.S. implant in a global pilot study of this novel therapy for treating a large and growing health problem.  "The first U.S. implant of the RespiCardia System brings concept to reality," said William T. Abraham, M.D., Professor of Internal Medicine and Director of Cardiovascular Medicine at The Ohio State University.  "The potential of this therapy is substantial, considering the very high prevalence of central sleep apnea in heart failure patients and in those with various neurological disorders."  It is estimated that approximately 35-40% of all heart failure patients have central sleep apnea. With the incidence of heart failure on the rise, there is even greater emphasis on diagnosing and treating this serious clinical problem.  

"The technology has the potential to not only provide a valid alternative to positive pressure devices for the first time, but also to revolutionize the way we diagnose and treat sleep disorders in cardiac patients, " said Dr. Rami Khayat, Associate Professor of Clinical, Pulmonary/Critical Care at The Ohio State University.

"The first U.S. implant of the RespiCardia System is a major milestone for our company.  Our goal is to demonstrate safety and efficacy through a worldwide study so we can provide this therapy to patients as quickly as possible," said Bonnie Labosky, CEO of Cardiac Concepts.  "This therapy has the potential to improve both central sleep apnea and heart failure."