ORANGEBURG, N.Y., June 29 /PRNewswire/ -- Impulse Dynamics (U.S.A.) Inc., a specialty medical device company, today announced the appointment of Dr. William Abraham, professor of medicine and chief of the division of cardiovascular medicine, Ohio State University and Dr. Alan Kadish, professor of medicine and associate-director of the cardiology division at Feinberg School of Medicine, Northwestern University, as Co-Principal investigators to lead its U.S. Phase II clinical trial evaluating the Company’s Optimizer(TM) System in patients with moderate to severe congestive heart failure. Known as the FIX-HF-5 study, the trial will investigate the safety and effectiveness of the Optimizer System in treating heart failure patients.
The goal of the FIX-HF-5 study is to enroll approximately 400 New York Heart Association (NYHA) Class III or Class IV heart failure patients at up to 50 U.S. sites and is anticipated to be completed by the first quarter of 2007. Based on a new technology now under investigation known as Cardiac Contractility Modulation (CCM), the Optimizer System delivers non-excitatory impulses to the heart intended to modify heart cell function.
“Unlike other devices for heart failure like pacemakers and defibrillators, the Optimizer System is designed to modulate the strength of contraction of the heart muscle rather than its rhythm,” said Dr. Kadish. “We believe that this unique technology could have value in assisting the growing number of patients who do not respond to current treatment methods.”
“The Optimizer’s primary value lies in the fact that it apparently improves the strength of the heart beat without adding to its overall workload,” added Dr. Abraham. “The combination of improved strength and increased efficiency of the heart makes us very optimistic about this particular therapy.”
The Optimizer System is an investigational implantable device designed for the treatment of patients with moderate to severe congestive heart failure. The system consists of a programmable implantable pulse generator (IPG), a portable programmer that interfaces with the implantable device and two right ventricular leads that deliver CCM signals to the heart muscle. The device also includes an external battery charger, permitting self-administered recharging of the Optimizer battery.
Currently, there are no other devices that provide the same type of therapy as the Optimizer. Pacemakers work to re-establish a normal heart rate through the administration of electrical pacing signals. Defibrillators work to stop abnormal rhythms in a heart that is beating chaotically or too fast by delivering an electric shock. The Optimizer works, in part, by regulating calcium within the heart cells which affects the contractility of the heart. The result is an increase in the pumping ability of the heart associated with a decrease in workload.
For more information regarding the study, please visit http://www.impulse-dynamics.com or contact: info@impulse-dynamics.com
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 The Optimizer System & CCM Therapy
The Optimizer System is designed for the treatment of patients with moderate to severe heart failure. Optimizer technology is based on a new method known as Cardiac Contractility Modulation (CCM). CCM is a method for treating failing hearts in which non-excitatory impulses are delivered to the heart during a period of time called the absolute refractory period (ARP). These signals do not initiate a heart beat (like a pacemaker does). Rather, these signals are intended to modify heart cell function for the treatment of heart failure. The implant procedure is minimally invasive, requiring only local anesthesia and is quite similar to the implant of other implantable cardiac devices.
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., located in New York, is the U.S. sponsor of the FIX-HF-5 study, is a wholly-owned subsidiary of Impulse Dynamics N.V. located in the Netherlands Antilles. Optimizer is a trademark of Impulse Dynamics N.V. For more information about the company you may go to http://www.impulse-dynamics.com.
Impulse Dynamics Inc.
CONTACT: Daniel Burkhoff, M.D., Medical Director and Vice President ofImpulse Dynamics (USA) Inc., +1-845-359-2389, or Yuval Mika, Ph.D., GeneralManager and Chief Scientist of Impulse Dynamics (Israel) Ltd.,+972-4-857-6756, or Sandra Ziv, Public Relations of Impulse Dynamics(Israel) Ltd., +972-54-805-1001
Web site: http://www.impulse-dynamics.com/
