Rox Medical's Coupler Device Shows Promise for Treatment-Resistant Hypertension

November 5, 2014—VIVA Physicians, Inc. announced that Eamon Dolan, MD, presented findings from the ROX-CONTROL HTN study during a late-breaking trials session at the VIVA 2014: Vascular InterVentional Advances meeting in Las Vegas, Nevada. The study is a randomized study evaluating the blood pressure-lowering effect of the Coupler device (Rox Medical, Inc.) in resistant hypertensive patients across European study sites.

According to the VIVA announcement, the background of the study is that there is a high prevalence of hypertension, particularly in older adults. Having an elevated blood pressure is the leading cause of both death and disability worldwide. Patients are considered to have resistant hypertension when they are compliant with three or more antihypertensive medications but fail to achieve blood pressure treatment targets. There are many challenges in the management of hypertension, such as patient compliance and the nonavailability of new potent pharmacotherapies. In recent years, there has been a move to overcome these limitations with the development of device-based treatment of resistant hypertension.

The Rox Medical CONTROL-HTN study is a randomized study evaluating the blood pressure-lowering effect of the Rox Coupler in resistant hypertensive patients across European study sites. The procedure involves the creation of a fixed 4-mm–diameter arteriovenous anastomosis between the external iliac vein and artery through the placement of a nitinol Coupler under angiographic guidance.

As summarized in the VIVA press release, in 83 randomized patients, there was a significant reduction in office blood pressure among those who underwent the procedure. This was also the case for ambulatory blood pressure tested over 24 hours. Results demonstrate a cushioning of blood pressure effect that may have benefits beyond blood pressure lowering alone.

The investigators found that there was a reduction in the variability of both systolic and diastolic blood pressure, particularly in the daytime period. There was also a reduction in maximum blood pressure, or the peak blood pressure, during the 24-hour period. Studies have shown this buffering effect may potentially reduce hypertensive damage brought about by extremes of blood pressure. Further studies are needed to further evaluate this exciting new therapy, concluded the CONTROL-HTN investigators in the VIVA summary.