WEDNESDAY, April 6 (HealthDay News) -- A new device, the Rheos System, can reduce blood pressure to target levels among patients with severe and uncontrolled hypertension through baroreflex activation, according to research presented at the American College of Cardiology's 60th Annual Scientific Session & Expo, held from April 2 to 5 in New Orleans.
In a multi-center, Phase III study, John D. Bisognano, M.D., Ph.D., of the University of Rochester Medical Center in New York, and colleagues implanted the Rheos System in 265 patients with resistant hypertension of >160/80 mm Hg who were taking at least three blood pressure drugs, including a diuretic. Patients were then randomized in a 2:1 ratio to baroreflex activation therapy for 12-month duration (Group A) or control treatment for the first six months followed by baroreflex activation therapy for the following six months (Group B). The Rheos System device was implanted just below the collarbone and delivered four to six volts of electricity to the carotid arteries, mimicking a spike in blood pressure that activates carotid baroreflex.
Among patients in group A, the investigators found that systolic blood pressure (SBP) decreased to target levels in 41 percent of patients after six months and 54 percent after 12 months. The investigators also found that, in the control group, SBP decreased to target levels in 21 percent of patients after six months and 46 percent after 12 months (six months of treatment). In addition, diastolic blood pressure also fell in both groups at six and 12 months.
"This system is safe, and its effect is as good as two or three drugs for people who are already taking five or six drugs and still can't control their hypertension," Bisognano said in a statement. "It's a good additional option for these patients."
The study was funded by CVRx Inc., the developer of the Rheos system; Bisognano disclosed a financial relationship with CVRx.
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