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 News Release - June 21, 2010

Four-Year Clinical Study Findings Show Significant and Persistent Reduction in Blood Pressure with Rheos(R) System

Data Presented at 20th European Meeting on Hypertension

MINNEAPOLIS & OLSO, Norway--(HSMN NewsFeed)--CVRx, Inc. announced today the four-year Rheos clinical results from the European study evaluating the Rheos® System at the European Society of Hypertension 20th Meeting. The system is the first device designed to treat hypertension (high blood pressure), a leading cause of heart and kidney disease, stroke and death. This device is a future treatment option for the millions of people who cannot control their blood pressure with medications.

Dr. Bram Kroon, Associate Professor, Vascular Medicine Specialist, Department of Internal Medicine, MUMC+, Maastricht, today presented the four-year results from the Device-Based Therapy of Hypertension (DEBuT-HT) study (Abstract 01, Oral Session 9D). The findings show a significant reduction in blood pressure in patients who have drug-resistant hypertension and had a systolic blood pressure above 160 mmHg prior to receiving the device. After four years of treatment, Rheos reduced systolic blood pressure by an average of 53mmHg (193 mmHg vs. 140 mmHg). Blood pressure was reduced significantly each year, with the largest decrease occurring in year four. Many of these patients were able to reach their blood pressure goal. Over this time period the number of medications that patients were taking to treat their hypertension decreased from an average of 5 at baseline to 3.4 medications at 4 years.

“These long-term results demonstrate the sustained effect that the Rheos System has on reducing blood pressure.” Dr. Kroon said. “The Rheos System offers us a new treatment option for patients who have a very difficult to treat disease. We are also learning that the Rheos System has the potential to improve the function and structure of heart,” he commented, referring to a second study presented earlier in the conference (poster presentation PP16 on June 19th).

Additional Rheos Data Presented at the European Society of Hypertension 20th Meeting

Additional data from the DEBuT and US studies were presented in three poster sessions and one oral presentation. These studies support the Rheos blood pressure reduction results and show early signs that it can also improve heart function and structure; and preserve kidney function.

* Baroreflex activation therapy improves functional capacity and reduces left ventricular mass: results from European and United States Trials of Rheos System (Abstract No. 94; Poster Session PP16)

* Baroreflex Activation Therapy (BAT) acutely improves central arterial properties in resistant hypertension patients (Abstract No. 02; Oral Session 3A)

* Achievement of blood pressure goal in patients with resistant hypertension treated with baroreflex activation therapy. (Abstract No. 108; Poster Session PP16)

* Functional safety in resistant hypertensive patients with baroreflex activation therapy (Abstract No. 298, Poster Session PP33)

The Rheos System and Baroreflex Activation Therapy®

The Rheos System uses Baroreflex Activation Therapy® (BAT®) that is designed to trigger the body's own natural blood flow regulation system to treat high blood pressure and heart failure. The Rheos 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 the Rheos System, 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 heart to fill with blood; and

* Kidneys to reduce fluid in the body, lowering both excessive blood pressure and workload on the heart.

This system includes three components:

* A small device that is implanted under the collar bone;

* Two thin lead wires that are implanted at the left and right carotid arteries and connected to the device; and

* The Rheos Programmer System, an external device used by doctors to noninvasively regulate the activation energy therapy from the device to the leads.

The therapy can be adjusted to meet each patient’s individual needs as they change over time, providing personalized treatment.

The Rheos System is CE Marked and approved for sale for hypertension patients in Europe.

About Hypertension

Hypertension causes an estimated one in eight deaths worldwide.1 In Europe, high blood pressure is estimated to effect over thirty percent of the population.2 Approximately 25 percent of people with hypertension cannot control their high blood pressure, despite the use of multiple medications.3, 4 Each incremental increase of 20 mmHg in systolic blood pressure or 10 mmHg in diastolic blood pressure above normal levels is associated with a two-fold increase in death rates from stroke, coronary heart disease and other vascular causes.3,4

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.

About the European Society of Hypertension

The European Society of Hypertension serves as a scientific forum that bridges current hypertension research with effective clinical treatment strategies for patients. For more information, visit eshonline.org.

About CVRx

CVRx, Inc. is a private company and is headquartered in Minneapolis. The company has developed the Rheos System for the treatment of high blood pressure and heart failure. For more information, visit www.cvrx.com.

Footnotes:

1. Heart Disease and Stroke Statistics. American Heart Association 2010 Update.

2. JAMA 2003; 289:2363-2369.

3. Lancet 2002;360:1903-1913.

4. JAMA 2003;289:2560-2572.

Caution: CVRx Rheos System is an investigational device and is limited by Federal (or United States) law to investigational use only.

CVRx, Rheos, Baroreflex Activation Therapy, BAT and HOPE4HF are trademarks of CVRx, Inc.

© CVRx, Inc. 2010. All rights reserved.


Source: CVRx

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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