Barts enrols first patients in resistant hypertension treatment trial

25 March 2013 (Last Updated March 25th, 2013 18:30)

St Bartholomew's and the London NHS Trust (Barts) in the UK, has enroled the first patients in the ROX Medical's international, controlled clinical study of ROX FLOW catheter procedure.

St Bartholomew's and the London NHS Trust (Barts) in the UK, has enrolled the first patients in Rox Medical's international, controlled clinical study of the Rox Flow catheter procedure.

The minimally invasive procedure places a small coupler between the artery and vein in the upper leg to reduce peripheral vascular resistance and offer long-term reduction in hypertension.

The procedure does not require heavy pain medications common to renal ablation techniques, according to the company.

Rox Medical CEO Rodney Brenneman said as the Flow procedure does not target the arteries of the kidneys, it may be of benefit to those patients who either cannot have or have failed to respond to renal denervation.

"The minimally invasive procedure places a small coupler between the artery and vein in the upper leg to reduce peripheral vascular resistance and offer long-term reduction in hypertension."

"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," Brenneman said.

The trial, Control-HTN, will randomise the patient to receive the treatment using the Rox Flow procedure for the treatment of resistant hypertension.

Bart's hypertension clinic director Dr Mel Lobo said resistant hypertension patients are a challenge for hypertension specialists and there is a need for new therapy options.

"We are very excited to be part of this trial which could lead to a novel new therapy option for resistant hypertension," Lobo said.

"We are impressed with the ease of the procedure, the need for minimal anesthesia and like the fact that it is reversible.

"We are looking forward to enrolling our next patients and watching their progress over the coming months."

The catheter procedure for hypertension is not approved for use in the US.