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Vasomedical, Inc. (“Vasomedical”) (OTC: VASO.OB), a world leader in the noninvasive treatment of cardiovascular diseases, today announced the online publication, on October 4, 2010 in the journal Circulation, of new evidence confirming improved endothelial function in patients with symptomatic coronary artery disease, in a randomized, sham-controlled clinical trial conducted by a well known cardiology group at the University of Florida in Gainesville. The Florida group led by Dr. Randy Braith and Dr. C. Richard Conti confirmed possible mechanisms of action of EECP® therapy as contemplated in a review paper by Dr. Bonetti, et al, at the Mayo Clinic in Rochester, MN and published in the Journal of the American College of Cardiology (JACC) in 2003.
The Florida study, entitled Enhanced External Counterpulsation Improves Peripheral Artery Flow-Mediated Dilation in Patients with Chronic Angina. A Randomized Sham-Controlled Study, cited the improvement in clinical outcomes, including a reduction of angina by 62% in Canadian Cardiovascular Society (CCS) Classification (compared to no change in the sham group) co-related with a 51% improvement in endothelial function as measured by peripheral flow-medicated dilation supported by a significant increase of potent vasodilators (nitric oxide 36%, 6-keto prostaglandin F(1α) 171%) and a reduction of endothelin-derived vasoconstrictive agents (endothelin-1 25%, asymmetrical dimethylarginine 28%). Also reported was a reduction in an array of inflammatory markers, the predictors of future cardiovascular events (high sensitivity-C reactive protein 32%, tumor necrosis factor-α 16%, monocyte chemoattractant protein-1 13%, and soluble vascular cell adhesion molecule-1 6%). In addition, there was a marked reduction in oxidative stress in lipid peroxidation 8-isoprostane (PGF2a) by 21%.
Commenting in an online article (http://www.theheart.org/article/1133261.do) highlighting the new study from the University of Florida, the principle investigator of the study Dr. Randy Braith said that, “Rather than waiting until their folks aren’t amenable to further revascularizations, maybe they’ll try this sooner in the game. I would prefer that EECP be an intervention before patients become end stage.”
“This addition to the large compendium of over 150 peer-reviewed publications on EECP® therapy is the latest in a number of randomized controlled studies on this safe and effective method of treating patients suffering with angina and the angina equivalent symptoms of shortness of breath, fatigue and atypical pain,” stated Larry Liebman, Vasomedical Vice President, Sales and Marketing. Other recent publications involving randomized studies include Coronary Collateral Growth by External Counterpulsation: A Randomized Controlled Trial by Steffen Gloekler, et al, at the University Hospital in Bern, Switzerland (Heart. 2010; 96:202-207), and Improvement of Fractional Flow Reserve and Collateral Flow by Treatment with External Counterpulsation (Art.Net.-2 Trial) by EE Buschmann, et al, on behalf of the Arteriogenesis Network at Charité Hospital - Universitätsmedizin Berlin, Germany (European Journal of Clinical Investigation. 2009 39(10): 866-75).
“In addition to the randomized clinical trials cited above, in an article published in September of this year in the International Journal of Cardiology, investigators at the Mayo Clinic reported on thirteen refractory angina patients prospectively enrolled in a study to examine the effects of EECP on circulating haematopoietic progenitor cells (HPCs) and endothelial progenitor cells (EPCs) using flow cytometric analysis and revealed an significant increase in HPCs over 35 1-hour course of EECP treatment,” Dr. John Hui, Chief Technology Officer for Vasomedical remarked. “In this study the researchers reported that the median Canadian Cardiovascular Society (CCS) angina class decreased and the Duke Activity Status Index (DASI) functional score increased significantly, both correlated significantly with the increase in circulating HPCs. These findings are the first to link the functional improvement observed with EECP treatment with increased circulating progenitor cells, as concluded by the authors.” Dr. Hui continued. “We remain encouraged by the results of these high quality studies on the EECP® therapy and look forward to more findings that provide better understanding of the therapy and eventually lead to broader application and acceptance of the therapy, therefore benefiting more patients all over the world.”
Tags: angina, ccs, congestive, controlled, eecp, failure, heart, randomized, study