Core Insights - CVRx, Inc. has initiated the BENEFIT-HF clinical trial, which is expected to be one of the largest therapeutic cardiac device trials for heart failure, supported by CMS Category B IDE coverage [1][4][5] - The trial aims to evaluate the Barostim™ device in a significantly expanded heart failure population, potentially tripling the indicated patient population for the device [3][5] Company Overview - CVRx, Inc. is a medical device company focused on developing innovative neuromodulation solutions for cardiovascular diseases [6] - Barostim™ is the first FDA-approved medical technology that uses neuromodulation to alleviate heart failure symptoms, receiving FDA Breakthrough Device designation in 2019 [2][6] Clinical Trial Details - The BENEFIT-HF trial will randomize 2,500 patients across approximately 150 centers in the U.S. and Germany, with the primary endpoint being a composite of all-cause mortality and heart failure decompensation events [3] - Enrollment for the trial is expected to begin in the first half of 2026 [3] Patient Population Criteria - The trial will include patients who remain symptomatic after receiving optimized guideline-directed medical and device therapies, have a left ventricular ejection fraction (LVEF) <50%, and NT-proBNP levels <5,000 pg/mL [7]