ROSLYN, N.Y., Jan. 17 /PRNewswire/ -- St. Francis Hospital, The Heart Center(R) 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 more than 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 $29.6 billion on caring for heart failure patients in 2006.
Heart failure is 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 and innovative technology with the potential to treat patients with Class III or Class IV heart failure," said Dr. Steven Greenberg, principal investigator of the study. "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 St. Francis Hospital
St. Francis Hospital, The Heart Center(R) is New York State's only specialty designated cardiac center and is one of the five busiest heart centers in the United States. A recognized leader in the diagnosis, treatment and prevention of cardiac disease, St. Francis is the only hospital in the metropolitan area with risk-adjusted mortality rates significantly below the statewide average for heart valve and valve/coronary artery bypass surgery, the most challenging forms of common cardiac surgery.(i)
St. Francis Hospital is a member of Catholic Health Services of Long Island (CHS).
Contact us at 1.888.HEART.NY or visit us at http://stfrancisheartcenter.chsli.org.
(i) New York State Department of Health RAMR for Valve and Valve/CABG
2001-2003.
St. Francis Hospital, The Heart CenterCONTACT: Paul Barry, +1-516-705-6657, paul.barry@chsli.org, or LibaNeymotin, +1-516-705-6665, liba.neymotin@chsli.org, both for St. FrancisHospital, The Heart Center
Web site: http://stfrancisheartcenter.chsli.org/
