CVRx Inc. has initiated the BENEFIT-HF clinical trial, a landmark randomized study supported by CMS Category B IDE coverage and intended to evaluate the impact of Barostim in a significantly expanded heart failure population.

Barostim is an implantable device that delivers electrical signals to baroreceptors located on the carotid artery, increasing baroreflex signaling, rebalancing the autonomic nervous system, and improving heart failure symptoms. Barostim secured U.S. Food and Drug Administration (FDA) approval in 2019 following Breakthrough Device designation and is now commercially available in both the United States and Europe.

“The BENEFIT-HF trial represents an important evolution in our clinical strategy to treat patients with heart failure,” CVRx Chief Medical Officer Philip Adamson, M.D., said. “Our earlier BeAT-HF trial provided robust clinical insights that showed clear improvement in symptoms and functional status within a segment of the heart failure population. BENEFIT-HF is now designed to evaluate morbidity and mortality in a broader heart failure population already being treated with standard of care.”

The BENEFIT-HF trial is expected to be one of the largest therapeutic cardiac device trials ever performed in heart failure, randomizing 2,500 patients in approximately 150 centers in the United States and Germany, according to the company. The primary endpoint will be a composite of all-cause mortality and heart failure decompensation events. Enrollment is expected to begin in the first half of 2026.

The BENEFIT-HF trial is designed to evaluate Barostim in patients with heart failure who:

• Remain symptomatic after receiving optimized guideline-directed medical and device therapies
• Have a left ventricular ejection fraction (LVEF) <50% (compared to the current Barostim indication of <35%)
• Have NT-proBNP levels <5,000 pg/mL (compared to the current Barostim indication of <1,600 pg/mL)

If successful, the BENEFIT-HF trial could expand the indicated patient population for Barostim approximately three-fold, significantly broadening access to this neuromodulation-based approach to heart failure management.

The Centers for Medicare & Medicaid Services (CMS) has approved Category B IDE coverage for the BENEFIT-HF clinical trial under IDE regulations (42 CFR § 405 Subpart B), effective Jan. 1, 2015, supporting patient access to therapy during the trial period and reinforcing the trial’s feasibility at scale.

“Heart failure remains one of the most significant unmet needs in cardiovascular medicine,” CVRx President/CEO Kevin Hykes stated. “Launching a trial of this magnitude demonstrates our leadership in the field and our commitment to advancing the science of heart failure care, building upon the patient outcomes experienced by Barostim patients in both clinical studies and real-world experience. We are seeing tremendous excitement from physicians and clinical partners for the BENEFIT-HF trial and the role Barostim may play in treating a much broader heart failure population.”

CVRx is a commercial-stage medical device company developing, manufacturing, and commercializing neuromodulation solutions for patients with cardiovascular diseases. Barostim is the first medical technology approved by FDA that uses neuromodulation to improve heart failure symptoms. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce heart failure symptoms.