Clinical Trial Findings Show Significant Benefits With CVRx® Rheos® System

CVRx announced that longer-term data from early Rheos clinical studies show significant reductions in hypertension and improvements in heart structure and function. The Rheos® Hypertension System, developed by the Minneapolis-based company, is the first device designed to treat hypertension, a leading cause of heart and kidney disease, stroke and death. The Rheos System activates the carotid baroreflex, the body’s own system for regulating blood pressure, and may provide a future treatment option for the millions of people who cannot control their high blood pressure (hypertension) with medications.

“We continue to see favorable clinical results that build on earlier findings from the Rheos clinical studies,” said Dr. Marcos Rothstein, Professor of Medicine, Division of Renal Diseases, Washington University School of Medicine. “We are optimistic that this novel therapy could offer a new treatment option to patients with drug-resistant high blood pressure. I am impressed with the impact this therapy has had on my patients. Many of them are now able to participate in daily activities that they could not do with uncontrolled blood pressure.”

Two-year and three-year data from European and U.S. early clinical studies evaluating the safety and clinical effectiveness of the Rheos System were presented today by Dr. Rothstein, as part of the Late-Breaking Clinical Trials III: Emerging Technologies Session (Session No. 407) at the 58th Annual Scientific Session of the American College of Cardiology (ACC). The findings show a significant reduction in blood pressure in patients with drug-resistant hypertension who have a systolic blood pressure of 160 mmHg or greater, despite being on at least three anti-hypertension medications, including a diuretic. The trials are assessing the safety and clinical efficacy of the Rheos System.

The presentation at ACC reported on office cuff measurement results after two and three years of active Rheos Therapy for the first European and U.S. patients enrolled in these trials at 11 medical centers: After three years of active Rheos treatment, systolic blood pressure was reduced by an average of 31 mmHg in 22 patients. The Rheos implants were well tolerated.

One-Year Data Show Improved Heart Structure and Function with CVRx Rheos Therapy.

Additional clinical data presented in a poster at ACC demonstrate that continuous use of Rheos Therapy in 33 Stage II hypertension patients (systolic blood pressure ≥ 160 mmHg) improves left atrial and ventricular chamber size and dimension and improves diastolic filling velocities. These benefits were incremental to those achieved with aggressive medical therapy. Specifically, Rheos Therapy decreased the size of the heart (left ventricular mass and left atrial dimension) and decreased diastolic blood flow velocities which would suggest an improvement in left ventricular filling pressure 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. A feasibility study is now under way to assess potential benefit of Rheos Therapy in advanced heart failure patients.

Dr. John Bisognano, Professor of Medicine and Director of Cardiac Rehabilitation and Clinical Preventive Cardiology at the University of Rochester, will present these study results (Abstract No. 1051-168) in Poster Session No. 1051 on Myocardial Function/Heart Failure – Clinical Nonpharmacological Treatment, March 31 at 9:30-10:30 a.m. ET. The title of the abstract is: “Improved Cardiac Structure and Diastolic Flow Velocities in Early-Stage Heart Failure with Chronic Treatment Using an Implantable Device: Results from European and United States Trials of the Rheos System.”

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.

Source:  CVRx

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