CVRx commences enrollment in study evaluating the Rheos System to treat heart failure

CVRx, Inc. reported the first enrollment of a patient in the HOPE4HF Trial, a study that is evaluating the Rheos System to treat heart failure. The Rheos System uses Baroreflex Activation Therapy^® technology, an entirely new non-pharmaceutical approach designed to treat cardiovascular disease. The HOPE4HF Trial is being conducted under an approved investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA). Data from this pivotal trial are intended to support a Pre-Market Approval (PMA) application to the FDA for use of the Rheos System in heart failure.

“After promising data from previous U.S. and European hypertension trials evaluating the Rheos System showed improvement in heart structure and function, we are excited to expand this therapy to heart failure,” said Nadim Yared, CEO and president, CVRx. “Today, many heart failure patients have no proven treatment options. We are hopeful the Rheos System will improve their quality of life, and reduce hospitalizations, as well as the risk of death.” Heart failure affects approximately 5 million people in the United States, and its frequency is growing with an aging population.

HOPE4HF (Health Outcomes Prospective Evaluation for Heart Failure with Left Ventricular Ejection Fraction ≥ 40%) is a pivotal (Phase III), 500-plus patient study designed to gather clinical data on the efficacy and safety of the Rheos System compared to the current standard of care in patients with symptomatic heart failure and a preserved ejection fraction. This type of heart failure, often also called diastolic heart failure, causes the heart to become stiff and thick, and prevents it from filling properly with blood. Diastolic heart failure accounts for up to 50 percent of heart failure cases.

“We are proud to enroll our first patient and participate in this landmark clinical trial,” said Dr. William Wickemeyer at Iowa Heart Center, who is an investigator in the HOPE4HF Trial and enrolled the first patient in the study. “In the absence of approved drugs or devices to treat this type of heart failure, there is a definite need for a new treatment option, and Rheos Therapy offers hope to these patients.”

HOPE4HF is assessing the safety of the Rheos System and whether it provides the following benefits to heart failure patients:

• Reduction of heart failure symptoms and improvement in quality of life;
• Extension of life expectancy;
• Improvement in heart function; and
• Reduction in the number of hospitalizations and emergency room visits due to heart failure.

“Diastolic heart failure is a major, growing public health problem with an urgent need for effective treatment options,” said Dr. Michael Zile of the Medical University of South Carolina, who is one of the Steering Committee members for the trial. “The HOPE4HF Trial is a well designed clinical trial that will provide clinicians with the evidence to determine if the Rheos System provides effective treatment for these patients.” Other Steering Committee members include: Dr. William Abraham at Ohio State University, Dr. William Little at Wake Forest University, and Dr. Fred Weaver at The University of Southern California.