Device Could Offer New Treatment Approach for Heart Failure
Minneapolis and New Orleans – Nov. 11, 2008 – Clinical data on the use of the CVRx® Rheos® System show Rheos Therapy significantly improved heart structure and function in patients with high blood pressure. Peter W. de Leeuw, professor of medicine and hypertension at theUniversity ofMaastricht in The Netherlands, presented the data in a November 11 (presentation #4426) at the American Heart Association (AHA) Scientific Sessions 2008 inNew Orleans. In addition, data from a pre-clinical study indicates that, after receiving Rheos Therapy, canines with heart failure are less likely to be induced into lethal ventricular heart rhythms, a risk factor for sudden cardiac arrest (poster session #2415).
CVRx Rheos Therapy Improved Structure and Function of Heart in Humans
Clinical data presented at AHA demonstrates that continuous use of Rheos Therapy in 32 Stage II hypertension patients (systolic blood pressure > 160 mmHg) remodels cardiac structure and improves heart function. Specifically, the Rheos Therapy increased the diameter of the aorta and left ventricular outflow tract diameter and decreased the size of the heart over a 12-month period. These changes reduce the amount of energy the heart uses to meet the needs of the body, and decreases stress on the heart.
“We are optimistic that the Rheos System will prove to be an effective means of treating heart failure,” said Dr. de Leeuw. “From the current clinical trial, we are expanding our evaluation the Rheos System and finding that not only does this unique therapy lower blood pressure, but it improves the efficiency of transferring blood from the heart to the arteries, which could improve the function of the heart and reduce heart failure symptoms.
Pre-Clinical Data Show Prevention in Lethal Heart Rhythms
Dr. Mengjun Wang and Dr. Hani Sabbah discussed data which show canines with heart failure are less likely to be induced into lethal ventricular heart rhythms, which can lead to sudden cardiac death, after long-term use of Rheos Therapy. At six months, the seven canines implanted with the Rheos device were much less likely to be induced into ventricular tachyarrythmias (excessively rapid heart rate) during programmed stimulation, than the four canines without a Rheos device implanted. These results demonstrate that the Rheos Therapy can prevent serious lethal heart rhythms in canines with heart failure. Studies in heart failure patients will be needed to confirm this benefit.
CVRx initially evaluated the Rheos System as a treatment for hypertension or high blood pressure. Many patients enrolled in early clinical evaluations of the Rheos System suffered from hypertension and had abnormal heart structure and function. Both conditions improved with Rheos Therapy in many of these patients. Worldwide, hypertension and heart failure are growing and leading causes of death. The Rheos System could provide a new treatment option for millions of people who cannot control these conditions with medications.
The Rheos System: Working with the Body’s Own Mechanisms to Reduce High Blood Pressure and Treat Heart Failure
The Rheos System uses the CVRx-patented Baroreflex Activation Therapy® technology that is designed to activate the carotid baroreceptors, central components of the body’s natural cardiovascular regulation system. When the baroreceptors are activated, signals are sent through 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 other parts of the body (heart, blood vessels and kidneys) that relax the blood vessels and inhibit the production of stress-related hormones. These changes enable the heart to increase blood output, while maintaining or reducing its workload, thereby reducing blood pressure when it is elevated and alleviating the symptoms of heart failure.
The Rheos System includes the following 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 pulse generator; and
• The Rheos Programmer System, an external device used by doctors to noninvasively regulate the activation energy from the generator to the lead wires.
About Heart Failure
In heart failure, heart function is impaired, resulting in shortness of breath, exercise intolerance and fluid retention. In the United States, heart failure is estimated to affect 5.2 million adults. Overall, heart failure is associated with a four-fold increased risk in death and a six to nine times increased risk of sudden cardiac death. The estimated direct and indirect costs of heart failure total $34.8 billion annually in the United States.1
Hypertension causes an estimated one in eight deaths worldwide.1 In the United States alone, high blood pressure affects approximately 73 million people.1 Approximately 25 percent of people with hypertension cannot control their high blood pressure, despite the use of multiple medications.2, 3 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.
U.S. Rheos Hypertension Pivotal Trial in Progress
CVRx received investigational device exemption (IDE) approval from the FDA to begin the Rheos Pivotal Trial to evaluate the safety and effectiveness of the Rheos System in treating hypertension. The trial is enrolling 300 patients at multiple clinical sites in the United Statesand in Europe. Prospective patients can call (888) 8BP-RISK (827-7475) or visit www.bloodpressuretrial.com, to learn more about the clinical trial.
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 CVRx, Inc.
CVRx, Inc. is a private company founded in 2001 and is headquartered in Minneapolis. The company has developed the Rheos System, an implantable system designed to treat hypertension (high blood pressure) and heart failure. The system uses CVRx-patented Baroreflex Activation Therapy technology, which activates the carotid baroreceptors, central components of the body’s natural cardiovascular regulation system. For more information, visit www.cvrx.com.
CVRx, Inc.9201 West Broadway Avenue Suite 650
1 Heart Disease and Stroke Statistics. American Heart Association – 2008 Update.
2 Lancet 2002;360:1903-1913.
CAUTION: CVRx Rheos System is an investigational device and is limited by Federal (orUnited States) law to investigational use only.