CVRx Commences BENEFIT-HF Trial of Barostim in Expanded Population of Heart Failure Patients

May 4, 2026—CVRx, Inc. announced the enrollment of the first patient in the landmark BENEFIT-HF trial, which is evaluating the company’s Barostim therapy.

The first patient in the trial was enrolled by Orvar Jonsson, MD, at North Central Heart, a division of the Avera Heart Hospital, in Sioux Falls, South Dakota.

“We are honored to enroll the first patient in the BENEFIT-HF trial,” commented Dr. Jonsson in the CVRx press release. “This study will evaluate Barostim therapy in a broader population of patients who remain symptomatic despite optimized guideline-directed medical therapy, generating important data that will further define Barostim’s position in the heart failure continuum.”

According to the company, the prospective, randomized controlled trial is designed to evaluate all-cause mortality and heart failure decompensation events in a significantly expanded heart failure population. The Centers for Medicare & Medicaid Services has approved category B investigational device exemption coverage for the BENEFIT-HF clinical trial, noted the company.

BENEFIT-HF will enroll 2,500 patients at approximately 150 centers in the United States and Germany. In January 2026, the company announced the initiation and design of the trial.