Rox Medical has announced the enrolment of the first two Irish patients, at Beaumont and Mater Private Hospitals, in the CONTROL-HTN randomised controlled trial of its Rox Flow procedure for the treatment of resistant hypertension.
Both patients were evaluated by hypertension specialists, Alice Stanton, of Beaumont Hospital, and Eamon Dolan, of Connolly Hospital in Dublin. One of the two patients was randomised to receive the Rox flow procedure, which was performed by Joseph Galvin, The Mater Private Hospital, Dublin, Ireland. The minimally invasive procedure was performed in the cardiac catheter lab in less than one hour.
Rox Medical’s flow procedure is a minimally invasive, catheter procedure whereby a small nitinol coupler is inserted between the artery and vein in the upper leg. The procedure reduces peripheral vascular resistance, thereby holding the promise of a meaningful long-term reduction in hypertension. According to a company press release, the flow procedure only involves the vascular structure, has an immediate effect, and is fully reversible.
“We congratulate the physicians at Beaumont, Connolly and Mater private hospitals for their first successful enrolments in the CONTROL-HTN study”, said Rox chief executive officer Rodney Brenneman. He added: “The ROX procedure is unique in providing a complimentary and/or alternative therapy option to the 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.”
The Rox Flow procedure for hypertension is not approved for use in the USA.