International EECP Patient Registry -IEPR- Achieves Important Milestone; Registry to Provide New Data on Patients with Combined Angina and Heart Failure.WESTBURY, N.Y. -- Vasomedical, Inc. (Nasdaq SC: VASO), a leader in the non-invasive treatment and management of cardiovascular diseases, today announced that Phase 2 of the International EECP EECP® Enhanced external counterpulsation, see there (R) Patient Registry (IEPR-2) has met its enrollment target of 2,500 patients. IEPR-2 collects additional data to better characterize angina patients with coexisting heart failure and other conditions. Forty-seven EECP treatment centers across the United States participate in this voluntary registry, enrolling and following consecutive patients treated for angina pectoris. Phase 1 of the IEPR IEPR Institute for Economic Policy Research (Stanford University) IEPR Integrated Engine Pressure Ratio (aviation) IEPR Inverse Elasticity Pricing Rule (economics) enrolled an initial 5,000 angina patients between 1998 and 2001. According to data generated during Phase 1, approximately 80 percent of patients experience a reduction in angina following treatment with EECP therapy. IEPR data have led to 14 manuscripts published in peer-reviewed journals and 61 presentations at major national and international cardiology meetings during the past five years. Both phases of the IEPR are coordinated by the Epidemiology Data Center at the University of Pittsburgh, Graduate School of Public Health. With the completion of enrollment for IEPR-2, physicians will gain additional information from the real-life experiences of cardiologists using EECP therapy to treat angina patients with heart failure. Patients are characterized by their demographics, medical history, symptom status and perceived quality of life immediately before EECP therapy, and at 6, 12 and 24-months post-therapy. The registry also captures data on medication use, emergency room visits, hospital admissions and subsequent invasive treatments, such as angioplasty and cardiac bypass surgery Bypass surgery A surgical procedure that grafts blood vessels onto arteries to reroute the blood flow around blockages in the arteries (arteriosclerosis). . IEPR Medical Director Andrew Michaels, M.D., FACC FACC Fellow, American College of Cardiology , FAHA FAHA Florida Air Hockey Association FAHA Fellow of the American Heart Association FAHA Florida Association of Homes for the Aging FAHA Fellow of the Australian Academy of the Humanities FAHA Finnish American Heritage Association , said, "IEPR-2, like Phase 1, tracks the safety, efficacy and long-term outcomes of angina patients treated with EECP therapy, but also captures specific information regarding the status of those patients suffering with a heart failure co-morbidity. These data provide the medical community with richly detailed patient profiles and accurately depicts their response to EECP therapy. Without the registry, our understanding of this effective, non-invasive therapy would be far less comprehensive." "We are extremely thankful for the generous voluntary efforts of all the participants in IEPR-2 and look forward to the many additional presentations and peer-reviewed articles these data will generate," said Vasomedical Vice President of Clinical, Regulatory and Quality Affairs Thomas Varricchione. "While controlled studies, such as our MUST-EECP (Multi-center Study of Enhanced External Counterpulsation enhanced external counterpulsation Cardiology A nonsurgical treatment of angina pectoris and CAD which ↑ blood flow to the heart by compressing blood vessels in the lower extremities. See MUST-EECP. ) and PEECH PEECH Prospective Evaluation of EECP in Congestive Heart Failure (Prospective Evaluation of EECP in Congestive Heart Failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. ) trials, play an important role in understanding the benefits of our innovative therapy, the IEPR documents outcomes in real-life settings more often seen in daily practice. Both data sets are critically important in advancing our understanding of EECP therapy," added Thomas Varricchione. About EECP(R) External Counterpulsation Therapy Vasomedical's advanced, state-of-the-art EECP(R) external counterpulsation systems are comprised of an air compressor, a computer console, a set of cuffs and a treatment table. To receive treatment, patients lie down on the table and have their calves and lower and upper thighs wrapped in the cuffs. The system, which is synchronized to the individual patient's cardiac cycle cardiac cycle n. A complete beat of the heart, including systole and diastole and the intervals between, beginning with any event in the heart's action to the moment when that same event is repeated. , inflates the cuffs with air to create external pressure when the heart is resting (diastole diastole /di·as·to·le/ (di-as´tah-le) the dilatation, or the period of dilatation, of the heart, especially of the ventricles.diastol´ic di·as·to·le n. ) and deflates the cuffs just before the heart beats (systole systole /sys·to·le/ (sis´to-le) the contraction, or period of contraction, of the heart, especially of the ventricles.systol´ic aborted systole ). The system's action, which pulses counter to the heart's beating, increases blood flow to the heart muscle, decreases the heart's workload and creates a greater oxygen supply for the heart muscle while lowering the heart's need for oxygen. Treatment is typically given in 35 one-hour-sessions over seven weeks; the benefits have been shown to persist for years. Researchers hypothesize hy·poth·e·size v. hy·poth·e·sized, hy·poth·e·siz·ing, hy·poth·e·siz·es v.tr. To assert as a hypothesis. v.intr. To form a hypothesis. that EECP(R) therapy may work by promoting the release of beneficial growth factors, by improving the neurohormonal milieu within blood vessels Blood vessels Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names. and by encouraging the proliferation of collateral blood vessels. Vasomedical's EECP(R) systems are the only counterpulsation devices shown in clinical studies published in major peer-reviewed journals to provide improvements in exercise capacity, peak oxygen consumption and quality of life. About Vasomedical Vasomedical, Inc. is primarily engaged in designing, manufacturing, marketing and supporting EECP(R) external counterpulsation systems based on the Company's proprietary technology. EECP(R) therapy is a non-invasive, outpatient therapy for the treatment of diseases of the cardiovascular system cardiovascular system: see circulatory system. cardiovascular system System of vessels that convey blood to and from tissues throughout the body, bringing nutrients and oxygen and removing wastes and carbon dioxide. currently indicated for use in cases of angina, cardiogenic shock cardiogenic shock n. Shock resulting from a decline in cardiac output that occurs as a result of serious heart disease, especially myocardial infarction. , acute myocardial infarction acute myocardial infarction ( Except for historical information contained in this report, the matters discussed are forward-looking statements that involve risks and uncertainties. When used in this report, words such as "anticipated," "believes," "could," "estimates," "expects," "may," "plans," "potential" and "intends" and similar expressions, as they relate to the Company or its management, identify forward-looking statements. Such forward-looking statements are based on the beliefs of the Company's management, as well as assumptions made by and information currently available to the Company's management. Among the factors that could cause actual results to differ materially are the following: the effect of the dramatic changes taking place in the healthcare environment; the impact of competitive procedures and products and their pricing; medical insurance reimbursement policies; unexpected manufacturing or supplier problems; unforeseen difficulties and delays in the conduct of clinical trials and other product development programs; the actions of regulatory authorities and third-party payers in the United States and overseas; uncertainties about the acceptance of a novel therapeutic modality by the medical community; and the risk factors reported from time to time in the Company's SEC reports. The Company undertakes no obligation to update forward-looking statements as a result of future events or developments. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion