ATLANTA, April 11 /PRNewswire/ -- Saint Joseph’s Research Institute at Saint Joseph’s Hospital 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 System is designed to deliver electrical impulses to the heart for treatment of moderate to severe heart failure. This study of the OPTIMIZER(TM) 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 health care system. It is estimated that the U.S. health care system will spend a projected $28.8 billion on caring for heart failure patients in 2004.
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(TM) System has the potential to help treat heart failure in a large number of patients.
“The OPTIMIZER(TM) System is an exciting technology with the potential to treat patients with Class III or Class IV heart failure,” said Dr. Nirav Y. Raval, a cardiologist specializing in advanced heart failure and cardiac transplant at Saint Joseph’s Hospital and Principle Investigator for this clinical study. “We have already begun enrolling patients in the FIX-HF-5 Study to evaluate the safety and effectiveness of the OPTIMIZER(TM) 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. We have already seen encouraging results in the Phase I study of which SJRI was an enrolling site.”
The investigational study, called FIX-HF-5 (Fix Heart Failure 5), is designed to investigate the effects of the OPTIMIZER(TM) 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 Impulse Dynamics
Impulse Dynamics is focused on the development of electrical therapies for the treatment of heart failure. The company’s proprietary technology stems from a scientific discovery regarding the electrical control of tissue function. Research and development at Impulse Dynamics is focused on refining the principle and practice of modifying tissue properties and function through the predictable and reproducible delivery of electrical signals. Impulse Dynamics (USA) Inc., the sponsor of the FIX-HF-5 study, is located in New York, with corporate headquarters of Impulse Dynamics N.V. in the Netherlands Antilles. OPTIMIZER(TM) is a trademark of Impulse Dynamics N.V. For more information, please visit http://www.impulse-dynamics.com/.
Saint Joseph’s Research Institute
CONTACT: Site Contact, Dr. Nirav Y. Raval, Principle Investigator, orLisa Mowatt, Clinical Trial Coordinator, +1-404-843-6079, pager,+1-404-896-6079, fax, +1-404-843-6051, or lmowat@sjha.org, or Lynn Peterson,Media Specialist, +1-404-851-5849, all of Saint Joseph’s Hospital
Web site: http://www.impulse-dynamics.com/