FDA approves updated instructions of use for implanted neuromodulation device for HF
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Key takeaways:
- The FDA approved revised instructions for use for a neuromodulation device for HF.
- The instructions now include long-term, postmarket data from the BeAT-HF randomized clinical trial.
CVRx Inc. announced the FDA approved its revised instructions for use for its baroreflex activation therapy device incorporating clinical data from the BeAT-HF randomized clinical trial.
As Healio previously reported, in certain patients with HF with reduced ejection fraction, use of the device (Barostim) was associated with improved N-terminal pro-B-type natriuretic peptide levels, quality of life and functional outcomes.
The device is indicated for patients who have NYHA class III HF, or class II with a recent history of class III, despite treatment with guideline-directed medical therapies; a left ventricular ejection fraction of 35% or less; and a NT-pro BNP level less than 1,600 pg/ml, according to a press release from the company.
The revised instruction for use now includes the primary endpoint results, the 6-, 12- and 24-month symptomatic data, win ratio and the all-cause mortality data, with postmarket analysis confirmation of the primary safety endpoint and postmarket effectiveness analyses suggesting a favorable effect of baroreflex activation therapy on all-cause mortality, according to the release.
“We are very pleased to receive this important validation from FDA of the long-term results of the postmarket phase of the BeAT-HF clinical trial and excited we can now share this data with physicians and patients,” Nadim Yared, president and CEO of CVRx, said in the release.
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