CHICAGO, Nov. 7 /PRNewswire/ -- Northwestern University Feinberg School of Medicine today announced it is enrolling participants 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 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 important new technology with the potential to treat patients with Class III or Class IV heart failure,” said Dr. Jeffrey Goldberger, professor of medicine at the Feinberg School of Medicine and principal investigator of the study. “We have already begun enrolling subjects 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 Northwestern University Feinberg School of Medicine
The Feinberg School of Medicine is a part of the vibrant educational and cultural community of Northwestern University, an independent private institution founded in 1851. The Feinberg School-one of Northwestern’s 11 colleges and schools-stands out among the nation’s medical schools. Consistently receiving high marks in U.S. News & World Report surveys, the medical school attracts bright and talented individuals to its faculty and student body.
The University, primarily through the Feinberg School, is part of the McGaw Medical Center of Northwestern University, an academic medical center in which the missions of education, research, and clinical services are paramount. Other McGaw members are Children’s Memorial Medical Center, Evanston Northwestern Healthcare, Northwestern Memorial Hospital, Rehabilitation Institute of Chicago, and Jesse Brown VA Medical Center (formerly VA Chicago Health Care System). Medical students and residents receive part of their education at these hospitals, and nearly all the attending staff members have faculty appointments at the Feinberg School.
Northwestern University
CONTACT: Elizabeth Crown, Senior Health Sciences Editor, NorthwesternUniversity, +1-312-503-8928, e-crown@northwestern.edu
