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First Implant of Medical Device to Lower Blood
Pressure Completed
 April
1, 2005 - Doctors at the University of Rochester Medical Center are the
first in the nation to implant an investigational medical device that
lowers blood pressure by activating the body's natural blood pressure
regulation systems.
The landmark procedure, performed yesterday, is
part of a Phase II clinical research trial to be conducted by a limited
number of medical centers in the United States. Called the Rheos Trial,
it is funded by CVRx Inc. of Minneapolis. Karl A. Illig, M.D., chief of
the Division of Vascular Surgery, is principal investigator for the
Rochester trial site. Cardiologist John D. Bisognano, M.D., Ph.D.,
associate professor of Medicine, who has been involved in development of
this technology, and nephrologist James A. Sloand, M.D., associate
professor of Medicine, serve as primary co-investigators.
"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," Illig says. "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."
"This device, if found effective, would offer a way
to lower blood pressure in patients who have not been able to control
their blood pressure with medications, and could conceivably reduce the
need for pressure-lowering medications in patients with lesser degrees
of hypertension," Illig says.
The Rheos system consists of a battery-powered
implantable generator, which is inserted under the skin near the
collarbone, and two carotid sinus leads, which run from the generator to
the left and right carotid sinus in the neck. While implantation is
slightly more involved, the general principle is quite similar to the
implantation of cardiac pacemakers.
Following the Phase II trial, if results continue
to be good, a larger, nationwide trial will begin.
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
effect 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
generally will be followed for life.
"Findings from this study could have a significant
impact on how we are able to treat hypertensive patients in the future,"
Illig says. "We are honored that the University of Rochester can be at
the forefront of this technology."
Illig, Bisognano and Sloand are conducting the
trial with vascular surgeons Mark Davies, M.D., Ph.D., Jeffrey Rhodes,
M.D., Cynthia Shortell, M.D., and Michael Singh M.D.
Reeo Baroreflex Hypertension Therapy System
CVRxฎ is developing the first implantable device to treat patients with
drug refractory hypertension. This new device is called the Rheos
Baroreflex Hypertension Therapy System. This system is made up of three
major components:
- Rheos Implantable Pulse Generator
- Rheos Carotid Sinus Leads
- Rheos Programmer System
The Rheos system works by electrically activating the baroreflex, the
system that regulates blood pressure. When activated by the Rheos
system, signals are sent to the central nervous system and interpreted
as a rise in blood pressure. The brain works to counteract this
perceived rise by dilating blood vessels to allow blood to flow more
freely, reducing the heart rate and influencing the kidneys to release
fluid. In this way, the Rheos system provides a physiologically rational
approach to reducing high blood pressure by allowing the brain to direct
the body's own control mechanisms. Reduction in blood pressue is
associated with a reduction in the risk of: stroke, heart attack, heart
failure and kidney disease.
The Rheos implantable pulse generator provides
control and delivery of the activation energy through the Rheos carotid
sinus leads. The leads conduct activation energy from the Rheos
implantable pulse generator to the left and right carotid sinus, which
are two main blood pressure control points. The Rheos programmer system
provides the ability to non-invasively communicate with the Rheos pulse
generator.
A surgical implant procedure is used to place the
pulse generator under the skin near the collarbone. The electrodes are
placed on the carotid arteries and the leads run under the skin and are
connected to the pulse generator. This device is under
clinical investigation at this time and not yet approved for
commercial sale.
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