It is the first device to be tested in a large-scale clinical trial for the treatment of hypertension and works by activating the body's natural blood flow regulation mechanism to reduce high blood pressure, according to the AAAS.
"The device works extremely well and there is a large group of patients who would benefit from this therapy, but we need to go back and identify this group more clearly," said John Bisognano, a lead study investigator from the University of Rochester Medical Center. "This outcome is not uncommon. While the initial results are not as crisp as we would expect, it is clear from looking at the data that there are therapeutic benefits to pursue."
"The device lowers blood pressure in a way that actually benefits patients beyond changing their numbers -- it improves the structure of the heart which in turn improves overall cardiac function," said Bisognano.
Though the therapy led to a considerable drop in blood pressure and had a good safety profile, it did not meet all of the study goals, study findings show.
Moreover, the device is needed to undergo more focused trial testing before the U.S. Food and Drug Administration will consider approving the treatment, researchers say.
People who do not respond to the typical treatment regimen for high blood pressure, which includes one to three medications, coupled with improved nutrition and exercise, have resistant hypertension. These patients are at a far greater risk for stroke, heart attack, heart failure, kidney disease and death, which is why new therapies like Rheos System are needed.
"Current drugs and lifestyle modifications can only do so much. I treat a huge number of people who are doing everything right -- taking their medications, maintaining a healthy diet, working out -- and they still develop resistant hypertension," noted Bisognano.