ROX Medical has crossed the halfway point in the CONTROL-HTN international, multi centre, randomized controlled hypertension trial. The milestone was met with the enrollment of the first patient from Prof. Markus van der Giet and Prof. Walter Zidek of the Charite Hospital, Benjamin Franklin Campus, Berlin. The CONTROL-HTN trial is evaluating the ROX FLOW procedure - creating a small connection between artery and vein in the upper leg - for the treatment of resistant hypertension.
ROX Medical's FLOW procedure is a minimally invasive, catheter procedure to place a small coupler between the artery and vein in the upper leg. The procedure reduces peripheral vascular resistance by diverting some of the higher-pressure arterial blood to the low pressure and highly compliant venous system; essentially restoring some of the lost compliance back into the vascular system.
"We have been thrilled by the enthusiasm of the clinical centers in the CONTROL-HTN trial and congratulate the Berlin physicians on the first enrollment in Germany," commented ROX CEO Rodney Brenneman.
The ROX FLOW procedure for hypertension is not approved for use in the U.S.