The new instructions for use incorporate key long-term data from the Minneapolis-based company’s BeAT-HF randomized clinical trial.
CVRx designed Barostim to deliver electrical pulses to baroreceptors in the wall of the carotid artery. These activate the body’s baroreflex, triggering an autonomic response to the heart. CVRx designed the therapy to restore balance to the autonomic nervous system, reducing the symptoms of heart failure.
The system holds FDA breakthrough device designation and FDA approval for use in heart failure patients in the U.S. It also holds CE mark approval for heart failure and resistant hypertension in Europe.
“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.”
More details on the CVRx labeling update
Barostim now has indication for NYHA Class III or Class II (who had a recent history of Class III) patients. These patients previously had treatment with guideline-directed medical therapies (medications and devices), have a left ventricular ejection fraction of ≤ 35%, and a NT-proBNP <1600 pg/ml.
The system delivers Baroreflex activation therapy to improve patients’ heart failure functional status. It also improves their six-minute hall walk and quality of life.
CVRx revised the clinical summary section of the instructions. This now includes the primary endpoint results from the company’s clinical trial. It also includes six-, 12- and 24-month symptomatic data, win ratio and all-cause mortality data.
