2026-05-04, 2:36:33 p.m.
MINNEAPOLIS, MN — May 4, 2026 — Leads & Copy — CVRx, Inc. (NASDAQ: CVRX) has announced the enrollment of the first patient in the BENEFIT-HF trial at North Central Heart – a division of the Avera Heart Hospital, in Sioux Falls, S.D.
Dr. Orvar Jonsson enrolled the first patient. BENEFIT-HF is expected to enroll 2,500 patients at about 150 centers in the United States and Germany. The trial is designed to evaluate all-cause mortality and heart failure decompensation events in a significantly expanded heart failure population, according to the company.
The prospective, randomized, controlled, multicenter trial is supported by CMS Category B IDE coverage.
“We are honored to enroll the first patient in the BENEFIT-HF trial,” said Dr. Orvar Jonsson, North Central Heart – a division of the Avera Heart Hospital. “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.”
Kevin Hykes, President and Chief Executive Officer of CVRx, said achievement of this early milestone reflects excitement in the healthcare community regarding this landmark trial, and strong execution by the CVRx team in partnership with BENEFIT-HF investigators. He added that the company is proud to collaborate with leading physicians in development of such meaningful clinical evidence and is excited to further characterize the patient benefits of Barostim therapy that they believe will drive long-term adoption.
The BENEFIT-HF trial is expected to continue through 2032. If successful, the trial could expand the indicated patient population for Barostim by approximately three times, significantly broadening access to the therapy.
CVRx is a commercial-stage medical device company focused on developing, manufacturing, and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim is the first medical technology approved by the FDA that uses neuromodulation to improve the symptoms of patients with heart failure.
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 the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area.
Source: CVRx, Inc.
