CVRx® Gains Full FDA Approval for Hypertension Study
Study will evaluate the second generation Barostim neo(TM)
Barostim neo is designed to use the body’s own natural blood flow regulation system to treat hypertension. The system works by electrically activating baroreceptors, the body’s natural blood pressure sensors that regulate cardiovascular function. When the Barostim neo is activated, signals are sent through neural pathways to the brain, which responds by telling the arteries to relax, the heart to slow down and the kidneys to reduce fluid in the body, lowering excessive blood pressure and workload on the heart.
According to Dr.
“Obtaining full FDA IDE approval to commence this study is an important step toward making Barostim Therapy available to treat hypertension patients in
For Potential Hypertension Study Participants
Key study qualifications include failing to reduce blood pressure while on at least four hypertension medications and having a systolic blood pressure greater than or equal to 160 mmHg. Study results are intended to support the premarket approval application (PMA) for Barostim neo to the FDA. Approximately 310 patients are planned to be enrolled in the trial. Individuals who are interested in learning more about the trial should visit www.bloodpressuretrial.com.
About Barostim neo
Barostim neo is a second generation device that uses CVRx-patented technology that is designed to trigger the body’s own natural blood flow regulation system to treat hypertension and heart failure. The 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.
This unique, patented technology has the potential to improve quality of life and reduce health risks associated with hypertension and heart failure, including heart and kidney disease, stroke and death. Other key potential benefits of Barostim neo include the following:
- 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;
- Is a non-destructive reversible treatment; and
- Provides 100% compliance to treatment, by automatically and continuously activating the baroreflex.
About CVRx, Inc.
CVRx, Inc. is a privately-held company founded in 2001 and is headquartered in
Editor’s Note: Blood pressure is typically recorded as two numbers – the systolic pressure (top number) over the diastolic pressure (bottom number). The systolic pressure is the pressure of blood in the vessels when the heart contracts. Diastolic pressure is the pressure of the blood between heartbeats, when the heart is at rest and is refilling.
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- Egan BM, JAMA. 2010;303:2043-2050.
CAUTION: Barostim neo(TM) is an investigational device and is limited by
CVRx and Barostim neo and Barostim Therapy are trademarks of CVRx, Inc. registered in
© CVRx, Inc. 2013. All rights reserved.
SOURCE CVRx, Inc.