ROX Medical has completed enrollment for CONTROL-HTN trial, an international multi center, prospective, randomized, controlled, blinded endpoint trial of the ROX Coupler for the treatment of arterial hypertension.
The CONTROL-HTN trial, NCT01642498, is evaluating the safety and efficacy of a percutaneous procedure creating a fixed connection between a central artery and vein in the upper leg – for the treatment of hypertension.
The primary outcomes are the safety and efficacy of the ROX Coupler in reduction of ambulatory and office blood pressure at six months post procedure.
ROX Medical chief scientific officer Dr Paul A Sobotka anticipates that last data obtained and results to be presented in the fall of 2014.
ROX Medical’s FLOW procedure is a minimally invasive, under one-hour, straight forward, catheter based procedure performed by interventional cardiologists, radiologists and vascular surgeons.
It places the ROX Coupler between a central artery and vein in the upper leg creating a fixed volume arterial-venous anastomosis, which immediately reduces blood pressure, and vascular resistance while increasing arterial compliance.
ROX Medical CEO Rodney Brenneman noted that the company is pleased with the continued strong interest in the ROX procedure to increase the choices available to patients and physicians for the treatment of hypertension.
"The immediately evident effects of the ROX treatment are gratifying to both the patient and interventional physician, and we are optimistic that this trial will demonstrate a durable and safe means of reducing blood pressure.
"The benefits of device mediated blood pressure therapy are obvious for patients unable or unwilling to sustain life long poly-pharmacy, and provide an absolutely unique and novel treatment strategy for severe hypertension."
The ROX FLOW procedure for hypertension is not approved for use in the US.