TYLER, Texas, March 1 /PRNewswire/ -- Patients with heart failure now have a new treatment option at the Trinity Mother Frances Heart Institute. Stan Weiner, MD, an electrophysiologist with Tyler Cardiovascular Consultants, PA, is enrolling patients in a clinical study to investigate the effectiveness of a new implantable pulse generator called the Optimizer(TM). Patients are evaluated for the study to determine whether a regimen of medications or the Optimizer is the best treatment method. There are currently 137 patients enrolled nationwide. The local study ranks 3rd nationally with 10 patients, five on medication and five who have received The Optimizer.
The Optimizer System is designed to deliver electrical impulses to the heart for treatment of moderate to severe heart failure. It is implanted under the skin on the right side of the chest and is similar in size to a pacemaker/defibrillator device, but differs in that The Optimizer is designed to actually strengthen the muscles of the heart rather than control the heart rate.
Heart failure is a disease caused by weak or damaged heart muscle that is unable to pump enough blood throughout the body and affects over five million Americans and 15 million patients worldwide. 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 who may not have other options to improve their status," said Dr. Weiner. "We have already implanted devices in five patients in the study to evaluate the efficacy of The Optimizer System. We still have availability for new patient enrollment and encourage patients to talk with their cardiologist about whether they could be a possible candidate for the device. The more patients we have enrolled, the better we can fully assess the potential of this device."
"The Trinity Mother Frances Heart Institute is continuously looking for new technology and techniques that bring healing and comfort to our patients," said Michael J. Vintges, vice president of cardiac services, Trinity Mother Frances Health System. "This new device is an additional tool for our ongoing effort to be a world-wide destination for cardiac and other health care. Physicians and clinicians from around the world visit our facility to observe and train in areas that include cardiac care and robotic surgery. We are proud to be partners with Dr. Weiner in this study."
The investigational study, called FIX-HF-5 (Fix Heart Failure 5), is designed to investigate the effects of the Optimizer System in approximately 420 U.S. patients with advanced heart failure.
Impulse Dynamics (USA) Inc., a specialty medical device company located in New York and a wholly owned subsidiary of Impulse Dynamics N.V, sponsors the Optimizer System study.
For more information on The Optimizer study at the Trinity Mother Frances Heart Institute, contact Dr. Stan Weiner at Tyler Cardiovascular Consultants, PA at (903) 595-5514. For more information on the Trinity Mother Frances Heart Institute, visit www.tmfhs.org or www.casattexas.org.
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.
Frances Heart Institute
MotherCONTACT: John Moore, Media Relations, +1-903-531-4542, for Mother FrancesHeart Institute
Web site: http://www.tmfhs.org/
