CVRx’s Barostim Trial Could Expand Treatment for Heart Failure Patients by 3x

Medical device company CVRx, Inc. has launched a major new clinical trial for its Barostim device. The BENEFIT-HF study will test the implantable system in a much larger group of heart failure patients. If successful, the trial could triple the number of people eligible for treatment with Barostim.

Barostim is an implantable device that sends electrical pulses to baroreceptors on the carotid artery. It aims to ease symptoms in patients with heart failure. The system gained FDA approval in 2019 and is now sold in both the U.S. and Europe.

The BENEFIT-HF trial will focus on patients with a left ventricular ejection fraction (LVEF) below 50% and NT-proBNP levels under 5,000 pg/mL. Its main goal is to track a combined measure of all-cause death and heart failure worsening events. Around 2,500 participants will take part across roughly 150 research sites in the U.S. and Germany. Patient recruitment is set to start in the first half of 2026. The Centers for Medicare & Medicaid Services (CMS) has already approved Category B Investigational Device Exemption (IDE) coverage for the study. CVRx plans to share more details about trial design, site activation, and enrollment schedules during its February earnings call.

The BENEFIT-HF trial marks a significant step in expanding Barostim’s use. With enrollment beginning in 2026, the study could lead to broader access for heart failure patients. A positive outcome may increase the eligible patient pool by nearly threefold.