CVRx® Enrolls First Patient in HOPE4HF Clinical Trial

Study Evaluates Use of Company’s Rheos® Therapy in Treating Heart Failure

MINNEAPOLIS--()--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.1

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.2

“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.

For more information on participant qualifications and other trial information go to www.heartfailuretrial.com or call 1 (888) 4HF-RISK [1-888-443-7475].

The Rheos System and Baroreflex Activation Therapy

The Rheos System 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 Rheos 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.

The Rheos System 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 Rheos 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.

This system includes three 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 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.

Early, Promising Rheos System Results

Initially, the Rheos System has been evaluated in patients with drug-resistant hypertension (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. Results presented at the European Society of Hypertension documented systolic blood pressure was reduced by an average of 37 mmHg at three years.3 The Rheos Hypertension Pivotal Trial is evaluating the device in 300 patients with resistant hypertension; enrollment will be completed in 2009. The Rheos System is CE Marked and approved for sale for hypertension patients in Europe.

Some patients enrolled in the Rheos hypertension feasibility studies also have early stage heart failure. The Rheos System was found to reduce the thickness of the heart and improve heart function in many of these patients.4, 5

About Heart Failure

Heart failure affects over 5 million people in the United States.1 It is a condition where the heart cannot pump enough blood to meet the body’s needs. People with heart failure have the following symptoms: general fatigue or weakness; shortness of breath; and swelling in legs and ankles. Studies have shown that when individuals do not have effective treatments to improve their heart failure condition, there is a high risk of death. The five-year mortality is very high for these individuals, with 74 percent dying.6 A specific type of heart failure called diastolic heart failure (or heart failure with preserved ejection fraction) has no proven effective treatments available today. Diastolic heart failure occurs when the heart has filling problems and becomes thick and stiff. New treatment solutions are needed for this condition.

About CVRx

CVRx, Inc. is a private company and is headquartered in Minneapolis. The company has developed the Rheos System for the treatment of high blood pressure and heart failure. For more information, visit www.cvrx.com.

Footnotes:

1. Lloyd-Jones DM, Larson MG, Leip EP, et al. for the Framingham Heart Study. Circulation. 2002;106:3068–3072.

2. Owan TE, Hodge DO, Herges RM, et al. N Engl J Med 2006;355:251-259.

3. Scheffers I, Schmidli J, Kroon AA, et al. Journal of Hypertension 2009;27(suppl 4):S421.

4. Bisognano JD, de Leeuw P, Bach DS, et al. JACC 2009;53(suppl A):A188.

5. de Leuw PW, Gangahar D, Bach DS, et al. Circulation 2008;118:S_887.

6. Lee DS, Gona P, et al. Circulation 2009;119:3070-3077.

Caution: CVRx Rheos System is an investigational device and is limited by Federal (or United States) law to investigational use only.

CVRx, Rheos, Baroreflex Activation Therapy, BAT and HOPE4HF are trademarks of CVRx, Inc.

© CVRx, Inc. 2009. All rights reserved.

Contacts

For CVRx, Inc.
John Brintnall, 763-416-2853
Chief Financial Officer
jbrintnall@cvrx.com
or
Mary McGrory-Usset, 651-308-8225
Corporate Communications
mmcgroryusset@comcast.net

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Contacts

For CVRx, Inc.
John Brintnall, 763-416-2853
Chief Financial Officer
jbrintnall@cvrx.com
or
Mary McGrory-Usset, 651-308-8225
Corporate Communications
mmcgroryusset@comcast.net