MINNEAPOLIS-ST. PAUL STAR TRIBUNE
The Food and Drug Administration has given a Minnesota company permission to begin U.S. clinical trials on a device that could offer a new way to treat high blood pressure.
Privately held CVRx Inc. will evaluate the safety and effectiveness of its Rheos Baroreflex Hypertension Therapy System -- a pacemaker-like device that uses electrical stimulation to treat the condition. Data from the blind study, which will involve 40 medical centers, will be used to bolster the company's application with the Food and Drug Administration for the device's introduction in the U.S. market.
High blood pressure, also known as hypertension, affects about 65 million people in the United States. The device is designed for those patients who have not responded to drugs, and those enrolled in the trial must be resistant to at least three anti-hypertension drugs. In addition, their systolic blood pressure must be at least 160.
CVRx already has conducted feasibility studies in the United States and Europe; the first patient received the device in 2004. Preliminary data have been positive, said Nadim ∂, the company's president and CEO.
"This is an important milestone for the company," he said.