ROX Medical, an early phase medical device company, has enrolled the first two Irish patients in a controlled study of its minimally invasive catheter procedure for the treatment of resistant hypertension.
Using a small nitinol coupler that is inserted between the artery and vein in the upper leg, the FLOW procedure reduces peripheral vascular resistance and offers long-term reduction in hypertension.
The FLOW procedure, which was evaluated in both patients at Beaumont Hospital and Connolly Hospital, has an immediate effect and is fully reversible, claims the company.
The study has randomised one of the two patients to receive treatment with the ROX FLOW procedure, which is performed in less than one hour in the cardiac catheter lab of the Mater Private Hospital in Dublin, Ireland.
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 said.
"We congratulate the physicians at Beaumont, Connolly and Mater Private hospitals for their first successful enrolments in the CONTROL-HTN study."
The FLOW procedure for hypertension is not approved for use in the US.