Pacemaker-Like Device For Those With Persistent Hypertension Being Tested
Research on a new medical device called the Rheos System was presented at the American College of Cardiology's 60th Annual Scientific Session & Expo in New Orleans. The device, like the now-popular pacemaker that regulates heart rhythms, is also implantable, but its purpose is to lower blood pressure.
Specifically, the Rheos System, developed by CVRx, Inc., is intended for persons with drug-resistant high blood pressure, or drug-resistant hypertension - those whose blood pressure levels do not respond to the commonly prescribed medications, diuretics, or to changes in lifestyles. These patients are at the highest risk for heart failure and stroke, so the Rheos System could be a life-saver.
Dr. John D. Bisognano, of the University of Rochester Medical Center in New York, and fellow investigators presented information about the Phase III study, in which the Rheos System was implanted in 265 patients with resistant hypertension (>160/80 mm Hg). Patients were then randomly selected to either receive the System's patented Baroreflex Activation Therapy® (BAT®) for 12 months (Group A), or control therapy for 6 months, followed by the BAT therapy (Group B).
BAT therapy works through the Rheos device to trigger the body's natural regulation of blood flow.
Forty-one percent of the patients in Group A had decreased blood pressure to target levels at the end of 6 months and, by the end of the 12-month period, 54 percent had accomplished target levels. In the B group, 21 percent reached target levels by receiving control therapy at the 6 month mark but, after BAT therapy, their 12 month tests showed that 46 percent had reached target blood pressure levels.
Apparently, however, there was rejection of the device by some patients, perhaps due more to their specific anatomies than anything else, and the study did not meet every one of it's goals. The researchers admit that further trials need to be more focused before the Rheos System can receive FDA approval.
Bisognano was, nevertheless, very positive about the future of the Rheos System.
"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," Bisongnano said. "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.
This device or something like it is crucial to those who, due to uncontrollable hypertension, are now ticking time bombs.