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Study in Circulation Validates Effect of Enhanced External Counterpulsation on Improved Coronary Blood Flow During Treatment Sessions

WESTBURY, N.Y.--(BUSINESS WIRE)--Sept. 9, 2002--

Using gold standard intracoronary measurement techniques,

researchers verify improved coronary hemodynamics comparable to that

achieved with intra-aortic balloon pumping s

Vasomedical (Nasdaq Small Cap: VASO) today announced that a study published in the September 3rd issue of Circulation, the official journal of the American Heart Association, verifies the beneficial effect of enhanced external counterpulsation on coronary blood flow produced by the Company's EECP(R) system.

The researchers noted that these beneficial hemodynamic effects achieved with EECP were comparable to effects achieved with intra-aortic balloon pumping, an invasive means of circulatory support commonly used by interventional cardiologists in the acute setting. The authors concluded that EECP might serve as a potential mechanical assist device.

"This study represents the first time we have been able to directly measure the acute hemodynamic effects of EECP therapy using current gold standard techniques, and it demonstrates that EECP unequivocally and dramatically increases coronary flow velocity and pressure," said Andrew D. Michaels, MD, lead author of the study and Co-Director of the Adult Cardiac Catheterization Laboratory at the University of California at San Francisco (UCSF) Medical Center. "We basically verified, in a very precise manner, the beneficial effects of EECP on blood flow in the heart." The study results showed that EECP significantly increased diastolic intracoronary pressure (+93%) and mean intracoronary pressure (+16%) and decreased systolic pressure (-15%). Average peak coronary blood flow velocity increased 109%. EECP resulted in diastolic augmentation of coronary artery pressure and flow, in addition to systolic unloading of the left ventricle. These effects increase oxygen delivery to the heart muscle while simultaneously decreasing oxygen demand. Earlier studies have linked higher levels of diastolic augmentation to better clinical outcomes with EECP.

"This was an exacting study with favorable data that represents a scientific landmark for EECP. It provides definitive proof supporting what we have up to now only been able to demonstrate indirectly through finger plethysmography, electrical bioimpedence or echocardiography, " said D. Michael Deignan, President and CEO of Vasomedical. "This study tells us that when a patient gets treated on our EECP system, there is an immediate hemodynamic benefit."

Conducted through grants from the American Heart Association and the UCSF School of Medicine and with technical support provided by Vasomedical, the study compared central aortic pressure, intracoronary pressure and intracoronary Doppler flow velocity in ten patients at baseline and then during EECP treatment. The measurements were taken inside the central aorta using a coronary catheter, and inside the coronary artery using a sensor tipped high fidelity pressure guidewire, and a Doppler flow guidewire.

About EECP - Enhanced External Counterpulsation

External counterpulsation has been studied for more than 40 years as a non-invasive method for the treatment of ischemic heart disease. Vasomedical's advanced, state-of-the-art EECP enhanced external counterpulsation system is composed 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, inflates the cuffs with air to create external pressure when the heart is resting (diastole) and deflates the cuffs just before the heart beats (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, and the benefits have been shown to persist for years. Researchers hypothesize that EECP may work by promoting the release of beneficial growth factors, improving the neurohormonal milieu within blood vessels, and by encouraging the proliferation of collateral blood vessels. Vasomedical's EECP 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.

EECP is currently reimbursed by Medicare and numerous private payers for the treatment of refractory angina. The reimbursement rate for a full course of 35 one-hour treatments ranges from $5,500 to $7,000. The Company estimates that one-third of the patients treated with EECP for refractory angina also have congestive heart failure.

About Vasomedical

Vasomedical, Inc. is primarily engaged in designing, manufacturing, marketing and supporting EECP external counterpulsation systems based on the Company's proprietary technology. EECP is a non-invasive, outpatient therapy for the treatment of diseases of the cardiovascular system, currently indicated for use in cases of angina, cardiogenic shock, acute myocardial infarction and most recently, congestive heart failure. The therapy serves to increase circulation in areas of the heart with less than adequate blood supply and may restore systemic vascular function. The Company is actively engaged in research to determine potential benefits of EECP therapy in the management of other major vascular disease states and diabetes. The Company provides hospitals, clinics and private practices with EECP equipment, treatment guidance and a staff training and maintenance program designed to provide optimal patient outcomes. EECP is a registered trademark for Vasomedical's enhanced external counterpulsation system. Additional information is available on the Company's website at www.vasomedical.com.

Except for historical information contained in this release, the matters discussed are forward-looking statements that involve risks and uncertainties. When used in this release, words such as "anticipate," "believe," "estimate," "expect" and "intend" 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 business and economic conditions; the impact of competitive products and pricing; capacity and supply constraints or difficulties; product development, commercialization or technological difficulties; the regulatory and trade environment; and the risk factors reported from time to time in the Company's SEC reports. The Company undertakes no obligation to revise any forward-looking statements as a result of future events or developments.

 
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