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January 5, 2024
CVRx’s Barostim Neuromodulation Device Receives Approval for Revised IFU
January 5, 2024—CVRx, Inc. recently announced that the FDA has approved revised Instructions for Use (IFU) for the company’s Barostim extravascular implantable neuromodulation device for patients with cardiovascular diseases.
The IFU now incorporates key long-term clinical data from the BeAT-HF randomized clinical trial.
The revised IFU document can be found at www.cvrx.com/ifu. The Clinical Summary section of that IFU can be found at pages 24 to 39.
According to the company, the 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 < 1600 pg/mlBarostim delivers Baroreflex Activation Therapy to improve patients’ heart failure functional status, six-minute hall walk, and quality of life.
Additionally, the revised Clinical Summary section of the IFU now includes the primary endpoint results, the 6-, 12-, and 24-month symptomatic data, the win ratio, and the all-cause mortality data.
As cited in the company’s press release, the Clinical Summary concludes:
In summary, the primary safety endpoint in the Pre-Market Phase was previously met and confirmed in the Post-Market Phase. In the Pre-Market Phase, all effectiveness endpoints were previously met, demonstrating 6-months improvements in 6MHW, quality of life, NYHA Class and NT-proBNP. The Post-Market Phase effectiveness primary endpoint of CV death and HF hospitalization was not met. Additional Post-Market Phase effectiveness analyses (Win Ratio, freedom from all-cause mortality) suggested a favorable effect of Barostim therapy. The totality of the 6, 12 and 24-month data demonstrated symptomatic improvements for heart failure patients who are NYHA Class III or Class II (who had a recent history of Class III) despite treatment with guideline-directed therapies and have a left ventricular ejection fraction ≤ 35% and a NT-proBNP < 1600 pg/ml.
The company stated that Barostim uses neuromodulation to improve the symptoms of patients with heart failure (HF). The device delivers electrical pulses to baroreceptors located in the wall of the carotid artery that activate the body’s baroreflex, which in turn triggers an autonomic response to the heart. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce HF symptoms.
The device has received FDA approval for use in HF patients in the United States and CE Mark approval for HF and resistant hypertension in the European Economic Area.
In March, the company announced the preliminary results of the BeAT-HF trial’s postmarket phase of the BeAT-HF trial were presented at THT 2023, the second annual Technology and Heart Failure Therapeutics conference held March 20-23 in Boston, Massachusetts.
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