RICHMOND, Va., April 11 /PRNewswire/ -- Virginia Commonwealth University Medical Center today announced it is enrolling patients in a clinical research study to investigate the safety and effectiveness of an investigational 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 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 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 Kenneth Ellenbogen, MD, professor of medicine in the VCU School of Medicine and director of the cardiac electrophysiology program. “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.”
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 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 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/.
About VCU and the VCU Medical Center: Located on two downtown campuses in Richmond, Va., Virginia Commonwealth University is ranked nationally by the Carnegie Foundation as a top research institution and enrolls more than 28,500 students in more than 170 certificate, undergraduate, graduate, professional and doctoral programs in the arts, sciences and humanities in 15 schools and one college. Forty of the university’s programs are unique in Virginia, and 20 graduate and professional programs have been ranked by U.S. News & World Report as among the best of their kind. MCV Hospitals, clinics and the health sciences schools of Virginia Commonwealth University compose the VCU Medical Center, one of the leading academic medical centers in the country. For more, see http://www.vcu.edu/.
Virginia Commonwealth University Medical Center
CONTACT: Dr. Kenneth Ellenbogen of Virginia Commonwealth UniversityMedical Center Department of Electrophysiology, +1-804-828-7565, Fax:+1-804-628-7270, kellenbogen@pol.net, or khall@hsc.vcu.edu