CVRx, Inc. (CVRX) Tuesday announced today that it has received the FDA approval for revised Instructions For Use or IFU for Barostim incorporating key long-term clinical data from the BeAT-HF randomized clinical trial.
The commercial-stage medical device company said IFU is a post-market phase validation.
Barostim delivers Baroreflex Activation Therapy to improve patients' heart failure functional status, six-minute hall walk, and quality of life.
In the Pre-Market Phase, all effectiveness endpoints were previously met, however, in the Post-Market Phase effectiveness, primary endpoint of CV death and HF hospitalization was not met.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.