CVRx Launches BENEFIT-HF Trial to Evaluate Barostim Therapy in Expanded Heart Failure Population
Key Insights
CVRx has initiated the BENEFIT-HF clinical trial, a landmark randomized study designed to evaluate Barostim (search) therapy in 2,500 heart failure patients across 150 centers in the U.S. and Germany.
The trial expands eligibility criteria to include patients with left ventricular ejection fraction <50% and NT-proBNP levels <5,000 pg/mL, potentially tripling the addressable patient population.
The Centers for Medicare & Medicaid Services has approved Category B IDE coverage for the trial, supporting patient access during the study period.
CVRx, Inc. has announced the initiation of BENEFIT-HF, a landmark clinical trial designed to evaluate its Barostim (search) neuromodulation device in a significantly expanded heart failure population. The randomized study will enroll 2,500 patients across approximately 150 centers in the United States and Germany, making it one of the largest therapeutic cardiac device trials ever performed in heart failure.
Trial Design and Patient Population
The BENEFIT-HF trial represents a major expansion of the current Barostim (search) indication, targeting patients with heart failure who remain symptomatic despite receiving optimized guideline-directed medical and device therapies. The study broadens eligibility criteria to include patients with a left ventricular ejection fraction (LVEF) <50%, compared to the current indication of <35%, and NT-proBNP levels <5,000 pg/mL, significantly higher than the current threshold of <1,600 pg/mL.
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, with the Centers for Medicare & Medicaid Services (CMS) providing Category B IDE coverage under IDE regulations, effective January 1, 2015.
Potential Market Impact
If successful, the BENEFIT-HF trial could expand the indicated patient population for Barostim (search) approximately three times, significantly broadening access to this neuromodulation-based approach to heart failure management. The expanded criteria would allow treatment of patients with less severe heart failure than currently approved.
"The BENEFIT-HF trial represents an important evolution in our clinical strategy to treat patients with heart failure," said Philip Adamson, MD, Chief Medical Officer of CVRx. "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 rigorously evaluate morbidity and mortality in a broader heart failure population already being treated with standard of care."
Technology and Regulatory Status
Barostim (search) 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. The device received FDA approval in 2019 following its designation under the FDA's Breakthrough Devices Program and is commercially available in both the U.S. and Europe.
Reimbursement Advancement
In a separate development, CVRx confirmed that Category I Current Procedural Terminology (CPT) codes for baroreflex activation therapy using Barostim (search) replaced Category III codes as of January 1, 2026. In the U.S. healthcare system, Category I CPT codes signify established procedures, supporting adoption, coverage, and reimbursement nationwide.
"We believe the new Category I CPT codes will enable more predictable and consistent reimbursement for Barostim (search) patients and healthcare professionals," said Kevin Hykes, President and Chief Executive Officer of CVRx, "and validate the important role of Barostim therapy in the heart failure treatment continuum."
Clinical Significance
Kevin Hykes emphasized the unmet medical need addressed by the trial: "Heart failure remains one of the most significant unmet needs in cardiovascular medicine. 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 outstanding patient outcomes experienced by Barostim (search) patients in both clinical studies and real-world experience."
CVRx plans to provide additional details regarding trial design, site activation, and enrollment timelines on its February earnings release call.