Download Baroreflex and Barostim neo™ System FAQs

Baroreflex and Barostim neo™ System FAQs
1. What is the baroreflex?
Baroreflex (“BARE-oh-REE-flex”) or baroreceptor reflex are terms used to describe the body's rapid
response system for dealing with changes in the blood flow regulation system.
The human body has its own physiologic mechanisms for sensing changes in blood pressure and other
blood flow changes. This natural system is largely located in the brain, as well as the walls of the carotid
arteries, which are the vessels in the neck that supply blood to the brain. Pressure sensors, called
baroreceptors, are found on the carotid artery and in the carotid sinus. These sensors measure and report
blood flow to the brain, which compares it to the body’s needs. For example, higher blood pressure is
good for exercising, while lower blood pressure is appropriate during sleep or other periods of reduced
activity.
2. What is unique about the Barostim neo™ System?
The Barostim neo™ System is a proprietary active implantable technology for the treatment of
hypertension and heart failure.
It uses the CVRx-patented technology to trigger the body’s own natural blood flow regulation system to
treat hypertension and heart failure. It is designed to significantly reduce blood pressure and treat heart
failure in patients who have no proven treatment options today. This unique technology offers the
potential to improve quality of life and reduce health risks associated with these conditions, including
heart and kidney disease, stroke and death.
Barostim neo can be adjusted to meet each patient’s individual therapy needs, making it the only
personalized medical device therapy for the treatment of hypertension with a CE marking.
Barostim neo is a fully reversible treatment option. The mechanism of action is electrical stimulation of
the baroreceptors, which does not alter or destroy the structure of the baroreflex. For this reason,
physicians can, if needed, turn the therapy OFF by simply pressing a button. This means that physicians
can easily observe the difference Barostim neo makes in blood pressure and other hemodynamic
parameters simply by turning it OFF and ON.
In addition, Barostim neo provides 100% compliance to treatment, by automatically and continuously
activating the baroreflex. The system does not rely on patients to be compliant to using their treatment,
which is a significant problem with medications.
3. What is included in the Barostim neo System?
o
A small device implanted under the collar bone;
o
One thin lead wire implanted on the carotid artery and connected to the device; and
o
The Programmer System, an external device doctors use to noninvasively regulate the activation
energy therapy from the device to the lead.
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4. How does the Barostim neo™ System work?
The Barostim neo system works by electrically activating the baroreceptors, the body’s natural blood
pressure sensors that regulate cardiovascular function. These baroreceptors are located on the carotid
artery. When activated by Barostim neo, signals are sent through neural pathways to the brain, which
responds by telling the:

Arteries to relax, making it easier for blood to flow through the body and reducing cardiac exertion;

Heart to slow down, allowing more time for the organ to fill with blood; and

Kidneys to reduce fluid in the body, lowering both excessive blood pressure and workload on the
heart.
How the Barostim neo™ System Works
1. Barostim neo sends signals via wire (lead) to special cells
in the carotid artery.
2. These signals activate the body’s baroreceptors.
3. Baroreceptors send signals to the brain.
4. The brain sends signals to the heart, kidneys and blood
vessels to improve cardiovascular function, and lower both
excessive blood pressure and workload on the heart.
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CVRx Contacts:
John Brintnall
Chief Financial Officer
[email protected]
Phone: 763.416.2853
Mary McGrory-Usset
Corporate Communications
[email protected]
Phone: 651.308.8225
CVRx, Inc.
9201 West Broadway Avenue
Suite 650
Minneapolis, MN 55445
www.cvrx.com
CAUTION: Barostim neo™ System is an investigational device and is limited by United States law to
investigational use. Exclusively for Clinical Investigations for the treatment of heart failure (in the
European Union).
CVRx, and Barostim neo are trademarks of CVRx, Inc. registered in the United States Trademark Office.
© CVRx, Inc. 2012. All rights reserved.
October 2012
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