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 ˇÓ 702 vs. 2898 ˇÓ 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 ˇÓ 1.9 vs. +2.1 ˇÓ 2.4 mmHg, p=0.0002). Reduction of pulse pressure was significantly higher in the treatment group compared to control (ˇV5.9 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.
About InterCure Ltd.
InterCure, a medical device company, has become a leader in the growing Personal Therapeutic Device category. Its broadly patented "device-guided paced breathing" technology platform, enables a systematic reduction in sympathetic outflow of the autonomous nervous system. InterCure is successfully selling the world's 1st hypertension treatment device, RESPeRATE„µ. With multiple published clinical trials, regulatory approvals in most key markets (FDA over-the-counter ("OTC") clearance, CE mark, Chinese SDA, and others) and a renowned scientific advisory board, RESPeRATE is rapidly becoming a part of the standard of care for the treatment of hypertension. (www.intercure.com, www.resperate.com)
The American Society of Hypertension, Inc. (ASH) is the largest US organization devoted exclusively to hypertension and related cardiovascular diseases. ASH is committed to alerting physicians, allied health professionals and the public about new medical options, facts, research findings and treatment choices designed to reduce the risk of cardiovascular disease. For more information, visit www.ash-us.org.
Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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