The device was developed by ROX Medical and named the 'Coupler'. The device is basically a paper clip sized implant, which is inserted between the artery and vein in the upper thigh, in a procedure lasting around 40 minutes under local anaesthetic.
Scientists led a randomised, blinded endpoint clinical trial with patients from multiple European Centres of Hypertension Excellence - including the Barts Blood Pressure Clinic at Barts Health NHS Trust in east London - all of whom had resistant high blood pressure and had not responded to at least three types of drug treatment.
The 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 were 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 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.