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.
The approval is based on clinical trial data from the Baroreflex Activation Therapy for Heart Failure Pivotal Trial (BeAT-HF). "With [this approval], we finally have an effective neuromodulation therapy for advanced heart failure patients who are not indicated for cardiac resynchronization therapy," said Michael Zile, MD, professor of medicine at the Medical University of South Carolina and chairperson of the BeAT-HF Executive Steering Committee.
About 5.7 million people in the United States have heart failure. Treatment includes addressing the underlying causes and reducing symptoms such as fatigue and swelling in the lower extremities that make physical activity difficult.
Barostim Neo is designed to electrically activate the baroreflex, the body's natural mechanism to regulate cardiovascular function. By activating this afferent pathway, Barostim therapy reduces sympathetic activity and increases parasympathetic activity, ultimately restoring autonomic balance. "After many decades of research in the field of neuromodulation,” said Nadim Yared, president and CEO of CVRx, “the Barostim Neo is the first device approved in the United States that uses the power of the brain and nervous system to target cardiovascular disease."
The device, which can be adjusted to meet each patient’s individual therapy needs, includes a pulse generator implanted below the collarbone and connected to a lead that attaches to the carotid artery. After the device is implanted, it sends electrical impulses to baroreceptors, which sense how blood is flowing through the carotid arteries and relay information to the brain. The brain, in turn, sends signals to the heart and blood vessels that relax the blood vessels and inhibit the production of stress-related hormones.
A prospective, multicenter randomized clinical trial with 408 patients with advanced heart failure showed that 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 improved their functional status as assessed by their NYHA classification. These clinically significant differences in treatment effect were observed despite an increase in the number of medications in the control arm.
The Barostim Neo System is 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%.
As part of the approval of this device, the FDA is requiring the manufacturer to conduct a post-approval study investigating the potential of the therapy to prolong life and reduce the need for patient hospitalization.
Sources: fda.gov, Aug. 16, 2019; CVRx, Inc.