CVRx Initiates BENEFIT-HF Trial of Barostim in Expanded Population

January 23, 2026—CVRx, Inc. a developer of neuromodulation solutions for patients with cardiovascular diseases, announced initiation of the BENEFIT-HF clinical trial.

According to CVRx, the randomized study is designed to evaluate the impact of the company’s Barostim neuromodulation device in an expanded population of heart failure patients.

The Centers for Medicare & Medicaid Services (CMS) has approved category B investigational device exemption (IDE) coverage for the BENEFIT-HF clinical trial under IDE regulations. The CMS coverage will support patient access to therapy during the trial period and reinforce the trial’s feasibility at scale, noted CVRx.

The company stated that the BENEFIT-HF trial will randomize 2,500 patients in approximately 150 centers in the United States and Germany. 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.

As outlined in the CVRx press release, 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 < 50% (the current Barostim indication is < 35%)
• Have NT-proBNP levels < 5,000 pg/mL (the current Barostim indication is < 1,600 pg/mL)

Barostim is an implantable device that delivers electrical signals to baroreceptors located on the carotid artery with the intention of increasing baroreflex signaling, rebalancing the autonomic nervous system, and improving heart failure symptoms. Barostim received FDA approval in 2019 and is commercially available in both the United States and Europe, noted CVRx.