Ever since Medtronic announced less than stellar news about the effectiveness of its renal denervation system in a clinical trial, it’s been a bit gloomy for those hoping to get off blood pressure drugs once and for all. Now there’s new hope that rests in a small implant from Rox Medical (San Clemente, CA) that has shown to work effectively in a trial organized among a number of European Centres of Hypertension Excellence.
The Coupler device is implanted into the upper thigh where it is used to create a connection, a sort of fistula, between the iliac artery and iliac vein, allowing some blood to flow between the two. The cath lab procedure takes about forty minutes to complete and doesn’t require sedation, a bit of local anesthetic being sufficient. Once implanted, the device helps reduce peripheral vascular resistance and lead to overall lowering of blood pressure. In the study of 83 patients, there was a reduction of 26·9 mm Hg in hypertension in those receiving the Coupler, while the control group only had a 3·7 mm Hg reduction. Interestingly, the device was shown to benefit even those that tried out renal denervation previously with little luck.
Here’s an animation from Rox Medical demonstrating the Coupler device:
Some details of the results from the study abstract in The Lancet:
83 (43%) of 195 patients screened were assigned arteriovenous coupler therapy (n=44) or normal care (n=39). Mean office systolic blood pressure reduced by 26·9 (SD 23·9) mm Hg in the arteriovenous coupler group (p<0·0001) and by 3·7 (21·2) mm Hg in the control group (p=0·31). Mean systolic 24 h ambulatory blood pressure reduced by 13·5 (18·8) mm Hg (p<0·0001) in arteriovenous coupler recipients and by 0·5 (15·8) mm Hg (p=0·86) in controls. Implantation of the arteriovenous coupler was associated with late ipsilateral venous stenosis in 12 (29%) of 42 patients and was treatable with venoplasty or stenting.
Study in The Lancet: Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial…
Queen Mary University of London: Revolutionary device found to lower blood pressure…
Product page: ROX COUPLER…
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