CVRx enrolls first patient in BENEFIT-HF heart failure trial
CVRx announced first-patient enrollment in the BENEFIT-HF trial, a 2,500-patient heart failure study across about 150 U.S. and German centers. The trial will evaluate all-cause mortality and heart failure decompensation events through 2032.
CVRx 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. BENEFIT-HF is expected to be one of the largest therapeutic cardiac device trials ever performed in heart failure, enrolling 2,500 patients at approximately 150 centers in the United States and Germany.
The prospective, randomized, controlled, multicenter trial is supported by CMS Category B IDE coverage and designed to evaluate all-cause mortality and heart failure decompensation events in a significantly expanded heart failure population. The first patient was enrolled by Dr. Orvar Jonsson.
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.
Barostim is the first medical technology approved by 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. 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 and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area.