Devices Cardiology

 News Release - April 28, 2008

New Implantable Device Designed to Lower High Blood Pressure May Offer Hope for Millions of Patients

Early Hypertension Clinical Trial Results Show Significant Reduction in High Blood Pressure

May - Hypertension Awareness Month - Recognizes High Blood Pressure as a Top Risk Factor for Stroke, Heart and kidney disease

April 28, 2008--(HSMN NewsFeed)--CVRx:

WHAT: May is Hypertension Awareness Month, and a new device for high blood pressure now in clinical trials is showing promise for treating U.S. hypertension (high blood pressure) patients whose condition is not controlled by drugs. Rheos® Hypertension (HT) Therapy is the only implantable device designed to lower high blood pressure. It uses the body’s natural blood pressure sensor (the baroreflex) to reduce blood pressure. Early hypertension clinical trial results showed a 39 mmHg reduction in systolic blood pressure at one year of use. High blood pressure is the number one risk factor for stroke, heart and kidney disease.

The Rheos HT Therapy is designed to electrically activate the carotid baroreceptors, the body’s natural pressure sensors. When the baroreceptors are activated, signals are sent through the neural pathways to the brain and interpreted as a rise in blood pressure. The brain works to counteract this perceived rise in blood pressure by sending signals to various parts of the body—including the blood vessels, heart and kidneys. The Rheos HT System was developed by Minneapolis-based CVRx, Inc. (www.cvrx.com). The Rheos pivotal trial is currently under way. To learn more about the trial, patients can call 1-(888) 8BP-RISK (1-888-827-7475) or visit www.bloodpressuretrial.com.

WHY: Hypertension affects approximately 73 million people in the United States alone. High blood pressure is the number one risk factor for stroke and causes an estimated one in eight deaths worldwide. 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.

According to the National Institutes of Health, approximately 25 percent of people with hypertension cannot control their high blood pressure, despite the use of multiple medications. These patients may not respond to drugs, or they may not be able to maintain their complex medication regimens. Early Rheos HT clinical results have shown the device has the potential to significantly reduce blood pressure in patients who cannot control their blood pressure with medications. One-year results from 13 patients showed a 39 mmHg average decrease in systolic blood pressure and a 26 mmHg average decrease in diastolic blood pressure.

HYPERTENSION STROKE FACTS:

May is Hypertension Awareness Month, sponsored by the U.S. Department of Health and Human Services. In the United States:

• High blood pressure is the number one stroke risk factor and accounts for an estimated 70 percent of all strokes. It is also one of the most important controllable risk factors for stroke prevention.
• Stroke is the number three cause of death.
• Twice as many women die from stroke each year than from breast cancer.
• Approximately 750,000 Americans suffer a stroke each year and 80 percent of strokes are considered preventable, according to the National Stroke Association.

INTERVIEW OPPORTUNITIES:

• Rheos study physicians
• Nadim Yared, president and CEO of CVRx

ADDITIONAL EVENTS DURING HYPERTENSION AWARENESS MONTH:

• May 4: ISHIB Worship Site Health Education Program (WSHEP)
• May 17: World Hypertension Day

CVRx BACKGROUND AND MEDIA KIT: CVRx is a private company founded in 2001 and headquartered in Minneapolis. For more information and a media kit, visit www.cvrx.com.

* CAUTION: The CVRx Rheos System is an investigational device and is limited by Federal law to investigational use only.

CVRx, Rheos, Baroreflex Activation Therapy, and BAT are registered trademarks of CVRx, Inc. © CVRx, Inc. 2008.

Source: CVRx

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Please address inquiries directly to the issuing company.