ROX Medical announced the first patient enrollment in the CONTROL-HTN international randomized controlled trial of the ROX FLOW procedure for the treatment of resistant hypertension (high blood pressure). The first patient was enrolled at UZ Brussel Hospital, Brussels, Belgium by Professor Danny Schoors and Dr. Sofie Brouwers.
According to the Centers for Disease Control, 1.2 billion people worldwide have high blood pressure and 50% of those have hypertension that remains uncontrolled (blood pressure above 140/90) and 15-20% have resistant form of hypertension. According to the American Heart Association, a 5 mmHg reduction in systolic blood pressure results in a 14% decrease in stroke, a 9% decrease in heart disease and a 7% decrease in overall mortality.
Professor Schoors performed the procedure in the cardiac cath lab in under one hour: "The ROX therapy is truly unique in the way it lowers blood pressure," said Prof Schoors. "The procedure is very straight forward, easy to perform and I like being able to see an immediate reduction in blood pressure upon placement of the Coupler," said Prof Schoors, "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."
ROX Medical's FLOW procedure is a minimally invasive catheter procedure to place a small coupler 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. Uniquely, the FLOW procedure only involves the vascular structure, has an immediate effect; and is fully reversible.
"We are excited to have begun this landmark study in hypertension," said ROX CEO Rodney Brenneman, "and we are very encouraged to have such and impressive group of hypertension and cardiology physicians interested and participating."
The ROX FLOW procedure for hypertension is not approved for use in the U.S.