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New device to treat hypertension.

Researchers at the University of Rochester are the first in the nation to implant an investigational medical device to help lower blood pressure. The device activates the body's natural blood pressure regulation system and is part of a Phase II clinical research study called the Rheos Trial.

"The Rheos system works by electrically activating the baroreflex system based in the carotid arteries in the neck, regulating blood pressure in a manner similar to a pacemaker regulating heart rhythm," said Dr. Karl A. Illig, chief of the school's division of vascular surgery and principal investigator for the Rochester trial site. "Low-level electrical stimulation to this area sends signals to the brain, 'telling' it to take action to lower blood pressure through a variety of mechanisms, including blood vessel dilatation, heart rate reduction, and promotion of fluid excretion by the kidneys. In this way, the Rheos System provides a physiologic approach to reducing high blood pressure by allowing the brain to direct the body's own control mechanisms."

If effective, the device would offer a viable option to patients unable to control blood pressure using conventional pressure-lowering medication.

The system consists of a battery-powered implantable generator inserted under the skin near the collarbone and two carotid sinus leads, which run from the generator to the left and right carotid sinuses in the neck.

Trial patients receive the device as part of a minimally invasive surgical procedure, followed typically by a one-or two-night stay in the hospital. The device initially will be tested for its effectiveness in the operating room and then turned off for one month, to ensure there are no health problems associated with the implant. At one month, a graduated scale of stimulation will be applied until the best possible blood pressure response is achieved. Patients will be evaluated on a regular schedule until the device receives FDA approval, and then they generally will be followed for life. Following the Phase II trial, if results continue to be good, a larger, nationwide trial will begin.
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Publication:Medical Update
Date:May 1, 2005
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