NEWARK, N.J., Dec. 5 /PRNewswire/ -- Newark Beth Israel 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. Newark Beth Israel Medical Center is an affiliate of the Saint Barnabas Health Care System.
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. David Baran, principal investigator of the study and research director of the Newark Beth Israel Medical Center Heart Failure Treatment and Transplant Program. "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 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 Newark Beth Israel Medical Center
As part of the Saint Barnabas Heart Center at Newark Beth Israel Medical Center, the Heart Failure Treatment and Transplant Program has become a leading site for investigational devices, new surgical techniques for end-stage CHF and for pharmaceutical and research protocols. The center has expanded its scope of services to include management of patients with pulmonary hypertension, myocarditis, and amyloidosis, working hard to ensure patient safety by investing heavily in new technologies, state of the art equipment and the latest in electronic medical records. To date, the center has performed nearly 400 transplants including 42 transplants in 2004. Newark Beth Israel's program is now one of the ten busiest in the U.S.
Newark Beth Israel Medical Center, an affiliate of the Saint Barnabas Health Care System, is a 673-bed regional referral teaching hospital. The Saint Barnabas Heart Center at Newark Beth Israel Medical Center provides a full range of cardiac services including adult and pediatric cardiac surgery, heart failure treatment and transplantation, interventional cardiology, electrophysiology, as well as clinical and diagnostic cardiology.
Newark Beth Israel Medical Center
CONTACT: Suzanne Santangelo, Public Relations for Newark Beth IsraelMedical Center, +1-973-926-7215, ssantangelo@sbhcs.com
