CVRx receives FDA approval for expanded labeling of Barostim

U.S. annual market opportunity increases based on real world adoption and strength of long-term BeAT-HF data

MINNEAPOLIS, Dec. 26, 2023 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, announced today that the U.S. Food and Drug Administration (FDA) has approved revised Instructions For Use (IFU) for Barostim incorporating key long-term clinical data from the BeAT-HF randomized clinical trial.

“We are very pleased to receive this important validation from FDA of the long-term results of the post-market phase of the BeAT-HF clinical trial and excited we can now share this data with physicians and patients,” said Nadim Yared, President and CEO of CVRx. “We remain grateful to all patients, investigators, research teams, the executive steering committee and FDA personnel, for supporting our efforts to conduct this landmark study over seven years, including the difficulties encountered during the COVID-19 pandemic.”

Labeling UpdateThe updated Indications statement for Barostim in the IFU now reads:

Barostim is indicated for patients who are NYHA Class III or Class II (who had a recent history of Class III) despite treatment with guideline-directed medical therapies (medications and devices), have a left ventricular ejection fraction of ≤ 35%, and a NT-proBNP