How the Rheos Device Lowers Blood Pressure Without Drugs

According to the American Heart Association (AHA), nearly 35 percent of adults have high blood pressure. Of those, 65 percent do not have their hypertension controlled. Why? Some patients find it difficult to deal with the side effects of their medication. Others, for any number of reasons, simply don't adhere to their doctor's instructions and recommended course of treatment. Another smaller number, those with severe hypertension, don't respond to either high blood pressure medications or changes in lifestyle. Enter the new implantable Rheos device.

I became aware of the Rheos device by way of a friend who is employed by the device's maker, Minneapolis-based CVRx, and I found the whole concept intriguing. In addition to a lunch visit with my friend, I also did some research of my own. What I found will no doubt be encouraging for some, but the system is not without drawbacks and could be considered a hypertension treatment of last resort.

So, how does the Rheos device work? Formally named the Rheos Baroreflex Hypertension Therapy System, it's usually called either the Rheos device or the Rheos system.

The baroreflex is the body's blood pressure regulation system. The device operates by a battery similar to a pacemaker and is implanted under the skin near the collarbone. There are two wire leads that run from the device to the right and left carotid arteries in the neck, where the baroreceptors are found. Electrical impulses are sent to the baroreceptors, which then "inform" the brain when the patient's blood pressure is too high. The brain responds by signaling the body's organs to dilate the blood vessels, reduce the heart rate, stop the production of stress-inducing hormones and excrete fluids.

The Rheos device has been the subject of clinical trials since March 2005 and is in the final phase of testing prior to FDA approval; it is already approved for use in Europe. According to the Rheos clinical trial website, 116 people have been implanted with the Rheos device as of May 2008, with encouraging results. Currently, researchers are seeking 300 individuals to participate in additional testing. This third phase will determine if the Rheos system is safe and works as the maker intends. The data from this last phase will be used by the FDA to determine whether the Rheos should be approved for commercial use in the U.S.

Assuming the device will eventually be approved by the FDA, the Rheos isn't for everyone. Implanting the device is considered an invasive surgery, and the battery life is limited. Also, there is no information yet available to indicate the long-term effects the Rheos system may have on the body.

Although weight loss, a healthy diet and exercise can effectively lower many cases of high blood pressure, other individuals either must or choose to resort to drugs. There are no fewer than 100 different high blood pressure drugs on the market, but for those few who suffer from drug resistant hypertension - meaning their hypertension cannot be controlled by medication - the Rheos device holds promise.

Resources:

AHA; http://www.americanheart.org/presenter.jhtml?identifier=4621

Rheos clinical trial website; http://www.bloodpressuretrial.com/