These results are significant in demonstrating for the first time that left atrial pressure monitoring, linked to a self-management strategy, can facilitate more optimal heart failure therapy and reduction of heart failure events, said Dr. Mark Carlson, chief medical officer and senior vice president of research and clinical affairs for the St. Jude Medical Cardiac Rhythm Management Division. St. Jude Medical will continue to focus on disease management technologies that will provide physicians more control in improving the lives of patients with heart failure.

The early results of the HOMEOSTASIS trial led to the establishment of the LAPTOP-HF (Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy) Study, a larger pivotal, randomized, controlled, prospective, multi-center clinical investigation. The LAPTOP-HF study will be conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) and is expected to begin in the first half of 2010.

Over five million Americans have HF with 550,000 new cases diagnosed each year. Heart failure occurs when the heart is unable to pump enough blood to meet the body ™s demands. To compensate, the heart must pump at an elevated filling pressure. Progression of HF over a period of days is known as acute decompensation and results in substantially raising the left atrial pressure. High levels of LAP directly force excess fluid into the lungs causing congestive symptoms, most commonly breathlessness. Approximately 90% of patients admitted to the hospital for HF have pulmonary congestion related to elevated LAP. Episodes of pulmonary congestion have a high associated mortality and result in a downward spiral of progressive cardiac deterioration.

SOURCE St. Jude Medical, Inc.