Healthcare Industry News: PHOENIX
News Release - November 3, 2006
Arizona Arrhythmia Consultants Seeks Heart Failure Patients For Investigational Study Evaluating Use of New Implantable Pulse Generator
Now Enrolling Patients in New Implantable Cardiac Device TrialPHOENIX, Nov. 3 (HSMN NewsFeed) -- Arizona Arrhythmia Consultants 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.
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 $29.6 billion on caring for heart failure patients in 2006.
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. Thomas Mattioni, 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 Arizona Arrhythmia Consultants
At Arizona Arrhythmia Consultants, we care for patients having problems with their heart's rhythm and its electrical signaling. There are many different forms of arrhythmias, or abnormal heart rhythms. These include tachycardia (heart beats too fast), bradycardia (heart beats too slow), atrial fibrillation, supraventricular tachycardia, Wolfe Parkinson White syndrome, ventricular tachycardia, neurocardiogenic (syncope) and other complex arrhythmias.
In our affiliated hospital's EP laboratories, physicians of our group offer a wide range of state-of-art electrophysiology and mapping procedures to patients with suspected rhythm abnormalities.
Our team of physicians, physician assistants, nurses and technicians are committed to and involved in clinical research focused on the cause of arrhythmias, and the development of the new tools and techniques to diagnose and treat patients with heart rhythm problems.
The excellence, experience and skill of the members of our practice, combined with true caring for our patients' well-being, makes us the leader in the diagnosis and care of patients with abnormal heart rhythms.
Source: Arizona Arrhythmia Consultants
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