Impulse Dynamics Launches Phase II Heart Failure Investigational Study In The U.S. Evaluating Use Of New Implantable Pulse Generator
ORANGEBURG, N.Y., April 13 /PRNewswire/ -- Impulse Dynamics (USA) Inc. today announced the start of a Phase II clinical study to investigate the safety and effectiveness of a new implantable pulse generator called the OPTIMIZER(TM) III and that the first patient in the Phase II study was successfully implanted yesterday at St. Joseph's Hospital in Atlanta, Georgia. The OPTIMIZER(TM) III 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 in the U.S. by Impulse Dynamics (USA) Inc., a specialty medical device company located in New York and a wholly-owned subsidiary of Impulse Dynamics N.V.
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. Based on a new method known as Cardiac Contractility Modulation (CCM), the OPTIMIZER(TM) delivers non-excitatory impulses to the heart during a period of time called the absolute refractory period (ARP). These signals do not initiate the heart to beat (like a pacemaker would do) but are intended to modify heart cell function for the treatment of heart failure. This phase of the trial is a follow-on to Phase I, which completed enrollment in December 2004 and included 50 patients implanted with an OPTIMIZER(TM) System.
"The OPTIMIZER(TM) System is an exciting technology with the potential to treat those underserved patients with Class III or Class IV heart failure who presently have no other options," said Dr. William Abraham, Chief Division of Cardiovascular Medicine, Ohio State University, who is serving as the Co-principal Investigator of this multicenter clinical study. "If proven safe and effective, the OPTIMIZER(TM) System has the potential to help this large and growing patient population."
The first implant was performed by Dr. Stephen Prater, an electrophysiologist at St. Joseph's Hospital in Atlanta. Dr. Nirav Raval, the Principal Investigator of the study at St. Joseph's said, "We are excited about our participation in this study because if the results support safety and effectiveness, the OPTIMIZER's Cardiac Contractility Modulation (CCM) technology could be a significant advance in heart failure treatment and may help a large number of patients."
According to the Heart Rhythm Society, clinicians will present additional data on the OPTIMIZER(TM) System in oral and poster presentations at the Heart Rhythm Society's 26th Annual Scientific Session which will be held in New Orleans, Louisiana from May 4 - May 7, 2005. More information is available at http://www.heartrhythm2005.org/.
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.
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.
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 U.S. 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.
Impulse Dynamics (USA) Inc.CONTACT: Daniel Burkhoff, M.D., Medical Director and Vice President,Impulse Dynamics (USA) Inc., +845-359-2389, or Yuval Mika, Ph.D., ChiefOperating Officer of Impulse Dynamics (Israel) Ltd.,+972-4-857-6756, or Sandra Ziv, Public Relations (Israel), +972-54-805-1001