Sleep Apnea Device Trial Enrolls First Heart Failure Patients
July 8, 2010 – The first patients have enrolled in an European pilot study to test an implantable device meant to help regulate sleep-disorder breathing in heart failure patients, Cardiac Concepts Inc. announced this week. The trial will examine the respiratory and cardiac benefits of Cardiac Concepts’ RespiCardia System when treating central sleep apnea (CSA) in patients with heart failure.
The system was successfully implanted in two male patients, ages 57 and 68 years, with ischemic cardiomyopathy and symptoms of moderate heart failure, as well as severe sleep breathing disorders. The trial is a 40 patient study being conducted in a number of centers worldwide. Implants are expected to begin in the United States in the coming months.
The RespiCardia System is an implantable device that uses small, electrical pulses designed to restore more natural breathing patterns in patients with sleep-disordered breathing. This respiratory management therapy may also improve heart failure and patients’ quality of life. The RespiCardia system is the first implantable device to treat central sleep apnea.