SAN CLEMENTE, Calif., March 25, 2013 /PRNewswire/ -- St Bartholomew's and the London NHS Trust (Barts) have enrolled their first patients in the ROX Medical CONTROL-HTN international randomized controlled hypertension trial. 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. Dr. Mel Lobo and Prof. Mark Caulfield enrolled the first patients at Barts Hospital. The first two patients randomized to the treatment group received the ROX procedure successfully performed by Dr. Ajay Kumar Jain and Prof. Anthony Mathur from the Cardiology department.
"We are very excited to be part of this trial which could lead to a novel new therapy option for resistant hypertension," commented Dr. Lobo. "We are impressed with the ease of the procedure, the need for minimal anesthesia and like the fact that it is reversible."
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. Because the FLOW procedure does not target the sympathetic nerves or arteries of the kidneys, it may be of benefit to those patients who either cannot have or have failed to respond to renal denervation. "Because the ROX FLOW procedure is reversible and leaves all other therapy options open, we are finding more patients and physicians who see this as a first choice device therapy option for resistant hypertension," commented ROX CEO Rodney Brenneman.
"Resistant hypertension patients are a challenge for hypertension specialists and there is a need for new therapy options," added Dr. Lobo. "We are looking forward to enrolling our next patients and watching their progress over the coming months."
The ROX FLOW procedure for hypertension is not approved for use in the U.S.
SOURCE ROX Medical