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California Pacific Medical Center Seeks Heart Failure Patients for Investigational Study Evaluating Use of New Implantable Pulse Generator

Posted on: Thursday, 21 July 2005, 09:01 CDT

SAN FRANCISCO, July 21 /PRNewswire/ -- California Pacific Medical Center today announced it is enrolling patients in a clinical study to investigate the safety and effectiveness of a new implantable pulse generator called the Optimizer(TM). The Optimizer(TM) System is designed to deliver electrical impulses to the heart for treatment of moderate to severe heart failure. This study of the Optimizer System is sponsored by Impulse Dynamics (USA) Inc., a specialty medical device company located in New York and a wholly-owned subsidiary of Impulse Dynamics N.V.

Heart failure is a disease that afflicts over 5 million Americans and an estimated 15 million patients worldwide. It is one of the most common causes of hospitalization and a growing and costly burden to the healthcare system. It is estimated that the U.S. healthcare system will spend a projected $28.8 billion on caring for heart failure patients in 2005.

Heart failure is a disease caused by weak or damaged heart muscle that is unable to pump enough blood throughout the body. If proven safe and effective, the Optimizer System has the potential to help treat heart failure in a large number of patients.

"The Optimizer System is an exciting technology with the potential to treat patients with Class III or Class IV heart failure," said Dr. Steven Hao, Medical Director of Electrophysiology at California Pacific Medical Center and of Northern California Heart Care. "We have already begun enrolling patients in the FIX-HF-5 Study to evaluate the safety and effectiveness of the Optimizer System. We look forward to completing new patient enrollment in order to fully assess the potential of this device to meet the needs of moderate to severe heart failure patients."

The investigational study, called FIX-HF-5 (Fix Heart Failure 5), is designed to investigate the effects of the Optimizer System in approximately 400 New York Heart Association (NYHA) Class III or Class IV heart failure patients at up to 50 U.S. sites.

About Heart Failure

Symptoms of heart failure result when the heart that is unable to pump enough blood to meet the energy needs of the body. A failing heart most often results from damage to the heart muscle due to injuries such as heart attack, untreated coronary artery disease or persistent high blood pressure. It can also occur as a result of genetic and/or molecular abnormalities or infections. The most common forms of heart failure are treated with drugs and electrical devices such as pacemakers and implanted defibrillators, but if symptoms continue to worsen, other therapies are needed.

About California Pacific Medical Center

California Pacific Medical Center, a Sutter Health affiliate, is one of the largest private, not-for-profit teaching medical centers in Northern California. We are a tertiary referral center providing access to leading-edge medicine while delivering the best possible personalized care. CPMC provides a wide variety of services, including, acute, post-acute and outpatient hospital care; home care and hospice services; preventive and complementary care; and health education. Through our Medical Education Program and our Research Institute, physicians at California Pacific Medical Center are able to bring health care innovation to the bedside.

California Pacific Medical Center

CONTACT: Christine McMurry, Media Relations Manager of CaliforniaPacific Medical Center, +1-415-600-2984, mcmurrcx@sutterhealth.org

Source: PRNewswire

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