CVRx (CVRX) announced initiation of the BENEFIT-HF clinical trial, a randomized study supported by CMS Category B IDE coverage and designed to evaluate the impact of Barostim in a significantly expanded heart failure population. The BENEFIT-HF trial is expected to be one of the largest therapeutic cardiac device trials ever performed in heart failure, randomizing 2,500 patients in approximately 150 centers in the United States and Germany. 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.
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