Early phase medical device company ROX Medical has completed enrolling first two Irish patients in a controlled, randomized study of its FLOW procedure for the treatment of resistant hypertension.
The FLOW procedure is a minimally invasive catheter procedure that uses small nitinol coupler that is inserted between the artery and vein in the upper leg to reduce peripheral vascular resistance and offers long-term reduction in hypertension.
In the study, one of the two patients were treated with the ROX FLOW procedure, conducted at the Mater Private Hospital in Dublin, Ireland.
The procedure, which has an immediate effect and is fully reversible, has been performed in less than one hour in the cardiac catheter lab, according to the company.
The FLOW procedure was evaluated in both Irish patients at Beaumont Hospital and Connolly Hospital.
ROX Medical CEO Rodney Brenneman said the FLOW procedure is a reversible therapy option that also offers an alternative and/or concomitant therapy option to other major device approach, renal denervation.
"Device approaches are becoming accepted as important additional therapies physicians may employ for the thousands of uncontrolled hypertensive patients throughout the world," Brenneman added.
The company said the minimally invasive catheter procedure for hypertension is not approved for use in the US.
