Healthcare Industry News: pacing lead
News Release - September 13, 2006
Impulse Dynamics Announces New Data Regarding Its Optimizer System Utilizing Cardiac Contractility Modulation (CCM) Technology
Data Presented in Late-Breaking Session Demonstrates the Effects of Optimizer System in Patients with Heart FailureSEATTLE, Sept. 13 (HSMN NewsFeed) -- Impulse Dynamics (U.S.A.) Inc. announced today new data supporting the company's Optimizer System which uses Cardiac Contractility Modulation (CCM) therapy for the treatment of heart failure. These new data, based on the largest randomized study to date evaluating Impulse's OPTIMIZER System were announced on September 13th. The release came in a late-breaking clinical trials session at the 2006 Heart Failure Society of America's 10th Annual Scientific Meeting underway in Seattle, Washington.
The need for innovative approaches to treat heart failure is critical. The condition, caused by a weak or damaged heart muscle unable to pump sufficient blood throughout the body, is an increasing burden on the U.S. healthcare system. It is expected that the disease will cost at least $29.6 billion dollars this year alone.(1) It is estimated that heart failure afflicts over 5 million Americans and an estimated 15 million patients worldwide.(2)
The study, known as FIX-CHF-4, evaluated the Optimizer System in the largest number of heart failure patients to date. The findings, summarized below, add to a growing body of evidence that the Optimizer System shows great promise for the treatment of heart failure.
"Notwithstanding the medical advances we have seen with beta-blockers, ACE inhibitors, cardiac resynchronization therapy and implantable cardiac defibrillators (ICDs), these methods still fall short in meeting the needs of all heart failure patients as many continue to suffer from exercise intolerance, frequent hospitalizations and high mortality," said professor Martin Borggrefe, M.D., director of Cardiology, Angiology and Pneumology of the Medical Clinic I, University Hospital Mannheim in Mannheim, Germany and lead investigator of the Optimizer study. "Today's findings are an important step in the evaluation of this new application in the hopes of becoming an easily deployable treatment made available to patients with otherwise untreatable symptoms," Borggrefe continued.
New Frontiers in Heart Therapy
The Optimizer System is CE-Marked in Europe and is currently under clinical investigation at major U.S. research and academic facilities. It consists of a pacemaker-like device and conventional pacing leads which deliver the therapy to the cardiac tissue. The device is implanted in a manner similar to a pacemaker procedure. Unlike conventional pacing methods, however, the Optimizer device utilizes Cardiac Contractility Modulation therapy in which electrical impulses are delivered to the heart after the heart has already initiated its contraction. Unlike conventional pacing signals, CCM increases the forcefulness of the heart's pumping action rather than initiating a new contraction.
FIX-CHF-4 Study Highlights
From May of 2002 to May of 2005, 126 patients received an Optimizer System implant and were randomized into one of two groups. For the first 12-week phase of the study, the Optimizer was activated in the first group of 62 patients and remained off in the second group of 64 patients. During the second 12-week phase, the groups crossed-over. The study was double blinded: neither the doctors nor the patients knew whether the Optimizer was operative.
During Phase I of the study, peak oxygen consumption increased similarly in both groups by ~0.8 ml/kg/min, independent of whether the device was turned on or off. In the second phase of the study, subjects who crossed over from non-active treatment to active treatment exhibited a further increase in peak oxygen consumption, whereas peak oxygen consumption decreased back to baseline in subjects who crossed from active treatment to non-active.
At the end of the second phase, there was a 1.25 ml/kg/min difference in peak oxygen consumption between the groups (p=0.02).
"The similar peak oxygen consumption rates seen in the two groups at the end of the first 12-week period indicates a relatively prominent placebo effect. However, the difference at the end of the full 24-week period showed that active treatment significantly improved maximal exercise tolerance," Dr. Borggrefe explained.
Minnesota Living with Heart Failure Questionnaire (MLWHFQ) scores, a quantitative measure of a patient's quality of life, also indicated that quality of life improved in both groups during the first phase. MLWHFQ returned towards baseline when Group 1 subjects crossed from active to non-active treatment; there was continued improvement in Group 2 subjects who crossed from non-active to active treatment, so that the change in MLWHFQ was significantly different between groups during Phase II (p=0.03).
"There have been no effective device-based treatments intended to enhance pumping force of the heart. We are therefore very encouraged by today's late breaking data," said Dr. Yuval Mika, chief operating officer of Impulse Dynamics. "Much of the research we have seen in the implantable heart device area lately has been a re-packaging of old technologies. There is an urgent and real need for breakthrough advances like the Optimizer System could potentially offer," continued Mika.
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. Optimizer is a trademark of Impulse Dynamics. For more information, please visit http://www.impulse-dynamics.com or contact Impulse at info@impulse-dynamics.com.
About HFSA
The Heart Failure Society of America (HFSA) is a nonprofit educational organization, founded in 1994 as the first organized association of heart failure experts. Today HFSA has over 1,700 members and provides a forum for all those interested in heart function, heart failure research and patient care. The Society also serves as a resource for governmental agencies (FDA, NIH, NHLBI, CMS). The HFSA Annual Scientific Meeting is designed to highlight recent advances in the development of strategies to address the complex epidemiological, clinical and therapeutic issues of heart failure. Additional information on HFSA can be found at http://www.hfsa.org.
(1) American Heart Association; http://www.americanheart.org
(2) American Heart Association; http://www.americanheart.org
Source: Impulse Dynamics
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