Cardiac Concepts initiates enrollment in European trial of RespiCardia System for CSA

Cardiac Concepts, Inc., a developer of medical devices to treat Heart Failure patients who experience breathing disturbances during sleep, announced today enrollment of the first European patients in a Pilot Clinical Trial. The purpose of the Pilot Study is to understand the respiratory and cardiac benefits of the RespiCardia™ System when treating a breathing disorder known as Central Sleep Apnea (CSA) in Heart Failure patients. Prof. Piotr Ponikowski, Principal Investigator of the Pilot Clinical Trial at The Medical University/4th Military Hospital in Wroclaw, Poland, commented that the system was successfully implanted in 2 male patients, ages 57 and 68 years with ischemic cardiomyopathy and symptoms of moderate heart failure. Despite optimal medical management, both experienced 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 using 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.

"We are excited to be the first in Europe to bring this new device to patients.  We now 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," said Prof. Ponikowski.

"We are very pleased to achieve this important milestone for Cardiac Concepts. 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," said Bonnie Labosky, CEO of Cardiac Concepts, Inc.