Barostim delivers electrical pulses to baroreceptors in the wall of the carotid artery. The pulses activate the body’s baroreflex, triggering an autonomic response to the heart.
CVRx designed the therapy to restore balance to the autonomic nervous system, reducing the symptoms of heart failure. The system holds FDA breakthrough device designation and FDA approval for use in heart failure patients in the U.S.
Minneapolis-based CVRx expects BENEFIT-HF to evaluate Barostim in a broader population of patients. Dr. Orvar Jonsson enrolled the first patient at North Central Heart – a division of the Avera Heart Hospital in Sioux Falls, South Dakota.
“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,” Jonsson said.
CVRx labeled BENEFIT-HF potentially one of the largest therapeutic cardiac device trials performed in heart failure. It plans to enroll 2,500 patients across approximately 150 U.S. and German centers. The study has support from CMS Category B IDE to evaluate all-cause mortality and heart failure decompensation events in the expanded population. CVRX expects the study to continue through 2032.
“Achievement of this early milestone reflects tremendous excitement in the healthcare community regarding this landmark trial, and strong execution by the CVRx team in partnership with BENEFIT-HF investigators,” said Kevin Hykes, president and CEO of CVRx. “We are proud to collaborate with leading physicians in development of such meaningful clinical evidence, and excited to further characterize the patient benefits of Barostim therapy that we believe will drive long-term adoption.”
