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44 CVRx enrolls first patient in HF trial with Rheos System By AMANDA PEDERSEN Medical Device Daily Staff Writer CVRx (Minneapolis) reported the first enrollment of a patient in the HOPE4HF trial, a study that is evaluating the company’s Rheos System to treat heart failure. The implantable device is already approved for treating hypertension patients in Europe. The Rheos uses baroreflex activation therapy technology, a non-pharmaceutical approach designed to treat cardiovascular disease, according to CVRx. The HOPE4HF trial is being conducted under an approved investigational device exemption from the FDA. The company expects that the trial will support a pre-market approval application to the FDA for use of the Rheos System in heart failure. “Often startups are about one product, one application,” Nadim Yared, president/CEO of CVRx, told Medical Device Daily. He said the HOPE4HF trial is important to CVRx because it means the company no longer offers just one product for one therapy. Now, the company has one platform with multiple applications, he said. The Rheos has already been evaluated in patients with drug-resistant hypertension, or high blood pressure. Results from European and U.S. feasibility clinical studies have shown it can significantly reduce blood pressure over a three-year period and the device is well tolerated, CVRx said. Results presented at the European Society of Hypertension documented systolic blood pressure was reduced by an average of 37 mmHg at three years. The Rheos hypertension pivotal trial is evaluating the device in 300 patients with resistant hypertension; enrollment will be completed this year, the company noted. “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,” Yared said. “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.” According to CVRx, heart failure affects about 5 million people in the U.S., and its frequency is growing with an aging population. HOPE4HF (Health Outcomes Prospective Evaluation for Heart Failure with left ventricular ejection fraction equal to or greater than 40%) is a Phase III, 500-plus patient study designed to gather clinical data on the efficacy and safety of the Rheos compared to the current standard of care in patients with symptomatic heart failure and a preserved ejection fraction. This type of heart failure, often called diastolic heart failure, causes the heart to become stiff and thick, and prevents it from filling properly with blood, the company said. Diastolic heart failure accounts for up to 50% of heart failure cases, according to CVRx. MEDICAL DEVICE INNOVATION 2010 “We are proud to enroll our first patient and participate in this landmark clinical trial,” said William Wickemeyer, MD, of Iowa Heart Center (Des Moines), 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.” In addition to assessing the safety of the device, the HOPE4HF trial is designed to determine 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. “We are extremely excited. We are confident about the data, as you can tell by the tone of my voice, it’s a great day for us,” Yared told MDD. “We wouldn’t do it if our confidence was not high enough in the high blood pressure . . . we’re excited.” The Rheos uses baroreflex activation therapy that is designed to trigger the body’s own natural blood flow regulation system to treat heart failure and high blood pressure. If the system is shown to affect the body as intended, it offers the potential to reduce the risk of death and improve quality of life in patients with heart failure, according to CVRx. The Rheos works by electrically activating the baroreceptors, the body’s natural blood flow regulation sensors that regulate cardiovascular function. These baroreceptors are located on the carotid artery. When activated by the system, signals are sent through neural pathways to the brain, which responds to these signals by telling the arteries to relax, making it easier for blood to flow to the body and reduce effort on the heart; heart to slow down, allowing more time for the heart to fill with blood; and kidneys to reduce fluid in the body, lowering excessive blood pressure and reducing workload on the heart. “There is one class of evidence today to support a treatment for this disease and that is to treat the high blood pressure . . . and that is exactly what our device does,” Yared said. This system includes three components: a small device that is implanted under the collarbone; two thin lead wires that are implanted at the left and right carotid arteries and connected to the device; and the Rheos programmer system, an external device doctors use to noninvasively regulate the activation energy therapy from the device to the leads. The therapy can be adjusted to meet each patient’s individual needs as they change over time, providing personalized treatment, CVRx noted. “Diastolic heart failure is a major, growing public health problem with an urgent need for effective treatment options,” said Michael Zile, MD, of the Medical University of South Carolina (Charleston), who is one of the steering To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
MEDICAL DEVICE INNOVATION 2010 45 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.” Some patients enrolled in the Rheos hypertension feasibility studies also have early stage heart failure, the company noted. The system was found to reduce the thickness of the heart and improve heart function in many of these patients. Because the HOPE4HF trial is just beginning to enroll patients and is intended to be a large trial of about 500 or more patients, Yared said the company does not really know yet how long it will take to complete the trial. However, he did say the company plans to start commercial efforts for the Rheos for high blood pressure before the heart failure study is complete. He estimated that there might be roughly two years difference between the two therapies going to market. (This story originally appeared in the Oct. 2, 2009, edition of Medical Device Daily) To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
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