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FDA Approves New Device to Improve Symptoms in Patients with Advanced Heart Failure based on BeAT-HF Clinical Trial

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FDA Approves New Device to Improve Symptoms in Patients with Advanced Heart Failure based on BeAT-HF Clinical Trial

The FDA has approved the Barostim Neo System (CVRx, Inc) for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronization therapy. This approval is based on the results from the Baroreflex Activation Therapy for Heart Failure Pivotal Trial (BeAT-HF).

The Problem

About 5.7 million people in the United States face heart failure. The treatment spectrum runs the gamut from addressing underlying causes and reducing symptoms, such as fatigue and swelling in the lower extremities that make physical activity difficult.

The Study

The Baroreflex Activation Therapy for Heart Failure Pivotal Trial (BeAT-HF) was a prospective, multicenter randomized clinical trial with 408 patients with advanced heart failure that evidenced the Barostim Neo is safe for patients in heart failure with reduced ejection fraction. It also improved patients’ quality-of-life score by 14 points, improved their exercise capacity by 60 meters in the standardized 6-minute hall walk test, and proved their functional status as assessed by their NYHA classification. These clinical differences in treatment were observed despite an increase in the number of medications in the control arm.

The Approval

The Barostim New System is now indicated for patients who have a regular heart rhythm, are not candidates for cardiac resynchronization therapy, and have a left ventricular ejection fraction of less than or equal to 35%. The FDA has required that the manufacturer conduct a post-approval study investigating the potential of the therapy to prolong life and reduce the need for patient hospitalization.

The Product

The product is designed to electrically activate the baroreflex, the body’s natural mechanism to regulate cardiovascular function.  Barostim therapy reduces sympathetic activity and increases parasympathetic activity, restoring autonomic balance. The device can be adjusted to meet different patient’s individual therapy needs, includes a pulse generator implanted below the collarbone and connected to a lead that attaches to the carotid artery. Once the device is planted it sends electrical impulses to baroreceptors, which sense how blood is flowing through the carotid arteries and relay information to the brain. Thereafter, the brain sends signals to the heart and blood vessels and inhibit the production of stress-related hormones.

The Sponsor

CVRx, Inc. is a privately held company founded in 2001 and headquartered in Minneapolis, MN. Their vision is to advance health for people everywhere, giving each patient a fuller life.  The company has raised over $300 million in venture capital and pioneers unique therapies that harness and harmonize the body’s natural systems.

Key Investigator

Michael Zile, MD, Professor of Medicine at Medical University of South Carolina, Chairperson of the BeAT-HF Executive Steering Committee

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