SAN CLEMENTE, Calif., Sept. 16, 2014 /PRNewswire/ -- ROX Medical today presented positive results from the CONTROL-HTN trial, an international multi-center, prospective, randomized, controlled, blinded endpoint study of the ROX Coupler for the treatment of arterial hypertension. The CONTROL-HTN trial, NCT01642498, evaluated 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 reduction of blood ambulatory blood pressure and office pressure at 6 months post procedure as well as the safety and efficacy of the ROX Coupler.
The CONTROL-HTN results were presented by study Principal Investigator, Mel Lobo, MD of St Bartholomew’s and the London NHS Trust (Barts) on behalf of the study investigators. The results showed a statistically significant reduction of Office blood pressure in the treatment group of -23/-17mmHg and a reduction of 24 hr Ambulatory blood pressure of -12/-13mmHg. In addition, the trial revealed a statistically significant reduction of hospitalized hypertensive crisis events in the treatment versus control group. A pre-specified sub-group of patients who had previously received renal denervation also demonstrated a statistically significant reduction in both office BP of -34/-15mmHg and Ambulatory BP of -14/-17mmHg. Additionally, the treatment group experienced a significant reduction of their hypertensive medications whereas the control group required significant increases in their hypertensive medications.
“We are very pleased to have completed a high quality trial that shows an immediate and significant reduction in blood pressure and importantly reduces the risk of hospitalized hypertensive crisis”, commented Dr Lobo, “we are in need of additional tools for addressing uncontrolled hypertension.”
ROX Medical’s FLOW procedure is a minimally invasive catheter based procedure performed by interventional cardiologists, radiologists and vascular surgeons in under one hour. The ROX Coupler is placed between the iliac artery and vein in the upper leg creating a fixed volume pressure relief. This results in an immediate reduction of blood pressure, vascular resistance and increased arterial compliance.
“The delivery of a safe, confirmable therapy with immediate response should provide gratification to patients and physicians alike” commented Paul A. Sobotka, MD, Chief Scientific Officer of ROX Medical, “this demonstrates the importance of non compliant or stiff artery to the pathology of hypertension and broadens the potential therapeutic landscape for chronic hypertension. "
The ROX FLOW procedure for hypertension is not approved for use in the U.S.
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SOURCE ROX Medical
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