Tampa, FL (Feb. 1, 2006) -- USF Health has begun a clinical study investigating the safety and effectiveness of a new implantable pulse generator to treat moderate to severe heart failure. The Optimizer™ is designed to improve heart strength using electrical impulses applied to the heart.

The University of South Florida is one of 50 U.S. sites – and the only one in the Tampa Bay area – enrolling patients older than age 18 in the investigational study, called FIX-HF-5 (Fix Heart Failure 5). Study sponsor Impulse Dynamics (USA) Inc., a specialty medical device company based in New York, expects to enroll approximately 400 patients with moderate to severe heart failure.

"Only about a third of patients with heart failure are eligible for the resynchronization pacemakers now available, and some patients who get the pacemakers still do not benefit," said USF principal investigator Anne Curtis, MD, professor of medicine and chief of cardiology.  "The Optimizer System uses an entirely new technology to improve heart function. If proven safe and effective, the device has the potential to help more patients with heart failure, not just those whose heart contractions are out of sync."

The Optimizer™ System works differently than pacemakers currently approved to treat heart failure, a disease caused by a weak or damaged heart muscle unable to pump enough blood throughout the body.

In some people with heart failure, electrical impulses that coordinate contractions of the heart's chambers are impaired. Standard pacemakers provide resynchronization therapy – that is, the devices stimulate both the heart's lower chambers to beat at the same time, helping improve pumping efficiency of the heart.

However, the Optimizer™ delivers precisely timed electrical impulses to the middle of the heart immediately after the heart's electrical system fires. During this split second, the heart muscle cannot be excited, no matter how strong the electrical signal delivered to the heart. Rather than making the heart beat, the Optimizer™ System's electrical signals are meant to change how heart cells metabolize calcium and thereby strengthen heart contractions.

"The target group for this novel technique is heart failure patients who are ineligible for resynchronization therapy and who have limited options," said Bengt Herweg, MD, assistant professor of medicine who is working with Dr. Curtis on the study.

Heart failure – one of the most common causes of hospitalization -- afflicts more than 5 million Americans and an estimated 15 million patients worldwide. The U.S. health care system will spend a projected $28.8 billon caring for heart failure patients in 2005.

- USF -

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 USF Health

USF Health is the University of South Florida's enterprise of researchers, teachers and clinicians dedicated to improving the full continuum of health. Its core is the colleges of Public Health, Nursing and Medicine, including a School of Physical Therapy, as well as the healthcare delivered by its 450 physicians and more than 100 nurse practitioners. In partnership with its affiliated hospitals, USF Health's research funding last year was $134 million -- more than half of which came from federal sources. Last year, USF health clinicians cared for more than 31,000 patients and oversaw 396,000 outpatient visits.