Rheos Hypertension Therapy: Implantable Blood Pressure Device

High blood pressure, also known as hypertension, is associated with an increased risk of stroke and cardiac events. High blood pressure can damage both arteries and small blood vessels. This, in turn, can damage the brain, heart and kidneys by reducing the amount of oxygen and nutrients these vital organs receive. CVRx is sponsoring a clinical study of an implantable blood pressure device. The device, called the Rheos High Blood Pressure Treatment and Baroreflex Hypertension Therapy System, is designed to activate the body's natural blood pressure regulation function.

Rheos clinical trial

According to the Rheos website, more than 150 people, in the U.S. as well as Europe, already have been implanted with the Rheos blood pressure device. Results from two small cohorts in early stage trials have been encouraging.

One cohort of 13 patients had "an average systolic blood pressure reduction of 29 mmHg (from 189 to 160) after three months of treatment and 39 mmHg (from 189 to 150) after 12 months."

Another cohort of 10 patients saw reductions of 24 mmHg in average systolic blood pressure after three months.

CVRx is now recruiting 300 patients for further study of the safety and effectiveness of the Rheos implantable hypertension therapy device. Patients must be at least 21 years old to participate. Other criteria for admission to the study include hypertension that is not controlled by two or more drugs. Over 50 medical centers are recruiting participants for the Rheos clinical trial.

Rheos hypertension therapy

Rheos hypertension therapy is based on an implantable blood pressure device. This device works with the body's baroreflex response. The baroreflex response is the body's natural way of regulating blood pressure.

For those participants accepted for surgery, the device designed to activate the body's baroreflex response will be implanted. For the first month after the baroreflex device is implanted, the device will remain turned off. After that initial time period, participants will be put into two random groups. One group will have the device turned on. In the other group, the baroreflex device will remain off.

Rheos implantable blood pressure device

The Rheos implantable blood pressure device is "considered a fundamentally new potential approach for hypertension treatment." According to the Rheos clinical trial website, the device has three parts: a battery pack and two wire leads.

The battery pack is the device's pulse generator. It is surgically implanted under the patient's skin near the collarbone. The two wires, called "leads," are connected to the battery pack . The leads "go under the skin from the battery powered pack to the left and right arteries" in the patient's neck. The leads are then "wrapped around the carotid arteries, which is where the baroreceptors are located."

Once the Rheos device is turned on, the body's baroreceptors, which help the body keep blood pressure at healthful levels, gets pulsed by energy from the battery pack. This energy activates the baroreceptors. This activation causes signals to be sent to the brain. These signals tell the brain, for example, that blood pressure is too high, so it's time to reduce it. The device uses a computer to calculate the appropriate pulse.

Saving lives

George Curtis, of Orlando, Fla., had hypertension to the extent that he woke up one day unable to breath. This "scare of his life" led Curtis to become one of the first patients in the United States to be implanted with the Rheos baroreflex device. According to Ivanhoe, Curtis previously had failed ten different hypertension medicines---but with the Rheos implantable device, Curtis' blood pressure is now well-controlled.

For more information, or to see if you or someone you love qualifies for the CVRx-sponsored Rheos study, visit: Rheos Clinical Trial for High Blood Pressure.

Sources:

"High Blood Pressure (Hypertension)," Mayo Clinic.

Bruce Goldfarb, "ASH Panel Proposes New Hypertension Definition; Revised scheme includes risk factors and co-morbidities," DOC News, American Diabetes Association.

"Rheos Clinical Trial for High Blood Pressure," Blood Pressure Trial.

"The Physiology of Blood Pressure Regulation," CVRx.

"Lowering Blood Pressure - Saving Lives," Ivanhoe.