Cardiac Concepts, Inc., a developer of medical devices to treat Heart Failure patients who experience breathing disturbances during sleep, announced 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.

About Heart Failure, Central Sleep Apnea and the RespiCardia System:

Heart Failure is a condition in which the heart cannot pump enough blood to meet the body's needs for blood and oxygen.(1) It is a common disease, affecting over 25 million people worldwide. Recently, it has been recognized that Heart Failure patients may suffer symptoms of feeling tired and daytime sleepiness due to breathing disturbances during sleep. In Heart Failure patients, a common form of sleep disruption is Central Sleep Apnea that occurs when the brain is not sending appropriate signals to the diaphragm that controls breathing during sleep. It is estimated that approximately 40% of Heart Failure patients will have Central Sleep Apnea.(2) Central Sleep Apnea can lead to the worsening of Heart Failure and has been shown to be associated with an increased risk of death.

The RespiCardia System consists of an implantable pulse generator and leads. It is designed to deliver small, electrical pulses at night during sleep to restore more regular breathing patterns thus reducing the episodes of Central Sleep Apnea. The RespiCardia System is not approved for commercial sale in the United States or Europe.

About Cardiac Concepts:

Cardiac Concepts, Inc. is a privately held company located in Minneapolis, MN focused on improving the outcomes for Heart Failure patients by developing an implantable stimulation therapy to treat Central Sleep Apnea.

Caution-Investigational device. Limited by Federal law to investigational use.

1. Exclusively for Clinical Investigation.

2. AHA. Heart Disease and Stroke Statistics 2009 Update. American Heart Association 2009.

Oldenburg et al. Sleep-disordered breathing in patients with symptomatic heart failure: A contemporary study of prevalence in and characteristics of 700 patients. Eur J Heart Fail 2007;9:251-7.

Source: Cardiac Concepts, Inc