Blood Pressure Treatment
American Society of Hypertension--Booth #2412--May 16, 2006--InterCure, Ltd., today announced new findings demonstrating the mechanism of action of its FDA-cleared hypertension treatment device, RESPeRATE. Details from four new studies will be presented at the American Society of Hypertension's 21st Annual Scientific Meeting (ASH 2006) in New York. The studies directly showed a reduction in the resistance of narrowed blood vessels to blood flow (peripheral resistance) and lower blood pressure.
The mechanism study, led by Dr. Kyung-Hoon Choe, from Wonju College of Medicine in South Korea, measured Systemic Vascular Resistance Index [SVRI] and other hemodynamic parameters, heart rate, and blood pressure of 22 hypertensive patients. The patient group was part of a 70-patient multi-center study using RESPeRATE for fifteen minutes a day throughout an eight week period. Overall, patients experienced a significant blood pressure reduction (average) of 12.6/5.3 mmHg (p<0.001) without a change in heart rate. Furthermore, peripheral resistance as measured by SVRI in the subgroup tested was significantly reduced from the baseline to end values, 3309 ' " 702 vs. 2898 ' " 621 dyne sec m2/cm5, respectively (p<0.001).
"The practical implication of our findings is significant," said Dr. Choe. "This direct physiological evidence gives us further confidence that the device lowers blood pressure and treats one of its most significant contributing factors." Narrowed small blood vessels are a primary factor in elevated blood pressure, as they increase the resistance to the body's blood flow and make the heart pump harder. Over time, this overloading of the heart and higher blood pressure can lead to heart failure, rupture of the vessel walls in the brain (stroke), eye damage, kidney failure and other life threatening conditions.
A separate study presented at the conference evaluated the blood pressure lowering effect of RESPeRATE in the diabetic population. The study is a randomized controlled study of non-insulin dependent diabetics with uncontrolled systolic blood pressure. The interim analysis of 60 patients demonstrates a significant difference in systolic BP change between the treatment and control groups (-9.5 ' " 1.9 vs. +2.1 ' " 2.4 mmHg, p=0.0002). Reduction of pulse pressure was significantly higher in the treatment group compared to control ( V5.9 vs. +3.6 mmHg, p=0.0007). Greater systolic BP reduction was found to be significantly correlated with the total time spent in slow breathing guided by the device (p=0.01) and no side effects were observed. Diastolic BP, initially controlled in both groups, was further decreased.
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