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 the University of Maastricht in The Netherlands, presented the data on November 11 at the American Heart Association (AHA) Scientific Sessions 2008 in New Orleans. In addition, data from a pre-clinical study indicate that, after receiving Rheos Therapy, canines with heart failure were less likely to be induced into lethal ventricular heart rhythms, a risk factor for sudden cardiac arrest.
CVRx Rheos Therapy Improved Structure and Function of Heart in Humans
Clinical data presented at AHA demonstrate that continuous use of Rheos Therapy in 33 Stage II hypertension patients (systolic blood pressure ≥ 160 mmHg) remodels cardiac structure and improves heart function. Specifically, the Rheos Therapy increased the 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 hypertensive patients with left ventricular hypertrophy,” said Dr. de Leeuw. “From the current clinical trial, we are expanding our evaluation of 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. This opens up the possibility to use of the device in patients with heart failure.”
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.