Revolutionary Implantable Device Lowers Blood Pressure Significantly, Found Superior to Standard Drug Therapies; New Approach Targets Mechanistic Aspects of Blood Circulation, Has Immediate Effect, and Is Pain-Free

A revolutionary device has been shown to significantly lower blood pressure among patients with uncontrolled high blood pressure, compared to those treated with usual drug measures, according to research from Queen Mary University of London and published online on January 22, 2015 in The Lancet. The device, developed by ROX Medical and named the “Coupler,” is a paper-clip-sized implant that is inserted between the artery and vein in the upper thigh, in a procedure lasting approximately 40 minutes under local anaesthetic. Researchers led a randomized, blinded-endpoint clinical trial with patients from multiple European Centers of Hypertension Excellence, including the Barts Blood Pressure Clinic at Barts Health NHS Trust in east London. All of the clinical trial patients had resistant high blood pressure and had not responded to at least three types of drug treatment. The research team compared the effects of the Coupler versus usual medical treatment in 83 patients, of whom 44 received the ROX Coupler therapy. Patients who received the Coupler experienced a significant and durable reduction in blood pressure. There was also a reduced number of hypertensive complications and hospital admissions for high blood pressure crises. The Coupler also worked well among patients who had failed to respond to renal denervation (another new approach to treating high blood pressure), suggesting that the Coupler targets different mechanisms of blood pressure control. However, patients who had not previously been treated with renal denervation experienced the same level or more of blood pressure reduction. In addition, unlike renal denervation, this new device-based treatment is fully reversible, immediate, and pain-free.
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