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CVRx Reports Preliminary Results of the BeAT-HF Post-Market Randomized Clinical Trial
The trial did not meet its primary endpoint, however, the totality of data supports Barostim’s use as an effective treatment for patients with heart failure
About this update from Cvrx, Inc.
[{"type":"text","content":"The trial did not meet its primary endpoint, however, the totality of data supports Barostim’s use as an effective treatment for patients with heart failure\nMINNEAPOLIS, Feb. 21, 2023 (GLOBE NEWSWIRE) -- CVRx, Inc. (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing Barostim™, an innovative extravascular implantable neuromodulation device for patients with cardiovascular diseases, announced today the preliminary topline results of the BeAT-HF, Baroreflex Activation Therapy for Heart Failure, post-market randomized clinical trial.The BeAT-HF post-market phase of the multi-center, prospective, randomized, controlled trial assessed 323 patients suffering from heart failure with reduced ejection fraction. The patients were randomized to two groups, treatment with Barostim and guideline directed medical therapy versus guideline directed medical therapy alone. The primary endpoint was a composite of cardiovascular mortality and heart failure morbidity (specifically, worsening heart failure events requiring treatment in the hospital or emergency department). The trial accrued 332 primary events and had a median follow-up of 3.7 years, corresponding to 1,037 patient-years.While the trial did not reach statistical significance on the primary endpoint, it did contain additional clinically meaningful prespecified analyses that favored Barostim, including: all-cause survival, free from LVAD and heart transplant,a hierarchical composite (“Win Ratio”) analysis of cardiovascular mortality, heart failure events and quality of life, anda clinical stability analysis. In addition, the safety profile of Barostim and the symptomatic improvement at 6 months, that were the basis for the FDA pre-market approval, were shown to be durable through 24 months (where data collection was prespecified). The Company will host a conference call at 9:00 am Eastern Time on Tuesday, February 21, 2023 to discuss the preliminary results of the BeAT-HF post-market phase clinical data and provide education about the prespecified analyses.The BeAT-HF post-market phase clinical data will be presented at the Transcatheter Heart Failure Therapies Conference (“THT”) on Tuesday, March 21, 2023 at 10:45 am Eastern Time in Boston.“On behalf of the Executive Steering Committee of BeAT-HF, I congratulate CVRx for conducti...