The controlled, international, randomized trial has enrolled first patient at UZ Brussel Hospital in Brussels, Belgium, to assess the potential of the ROX FLOW procedure.

The catheter procedure is a painless process where a small coupler is placed between the artery and vein in the upper leg to minimize peripheral vascular resistance, thus reducing hypertension.

UZ Brussel Hospital spokesperson Danny Schoors said the procedure is easy to perform and gives immediate reduction in blood pressure upon placement of the Coupler.

"I have been impressed by the pilot study data for the ROX device and look forward to seeing the data from other centers in this very important randomized, multi-center trial," Schoors added.

ROX CEO Rodney Brenneman said, "We are very encouraged to have such and impressive group of hypertension and cardiology physicians interested and participating."

The company said the minimally invasive procedure for hypertension is not approved for use in the US.