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FDA Approves Expanded Label for Barostim Neuromodulation System in Heart Failure Treatment

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Mason Walker
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FDA Approves Expanded Label for Barostim Neuromodulation System in Heart Failure Treatment

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In a significant development for heart failure (HF) treatment, the US Food and Drug Administration (FDA) has approved an expanded label for the Barostim neuromodulation system. The decision is based on longer-term, post-marketing clinical data from the BeAT-HF randomized clinical trial. This move represents a significant expansion in the availability of this treatment for HF patients and could have substantial impact on the quality of life for many suffering from this condition.

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Detailed Specifications of the Expanded Label

The updated labeling now includes patients with New York Heart Association (NYHA) class III or class II HF who have a recent history of class III, despite being treated with guideline-directed medical therapies. It also includes patients who have a left ventricular ejection fraction (LVEF) ≤35% and N-terminal pro-B-type natriuretic peptide (NT-proBNP) <1600 pg/ml. These updates provide a broader scope for the use of the Barostim system in HF treatment.

About the Barostim Neuromodulation System

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The Barostim system, which resembles a standard pacemaker, is implanted subcutaneously below the left or right collarbone, with the lead positioned at the adjacent carotid sinus. The system stimulates carotid baroreceptors to trigger an autonomic response to the heart, restoring balance to the autonomic nervous system. This unique approach has demonstrated significant improvements in heart failure functional status, six-minute hall walk, and quality of life.

Results and Implications of the BeAT-HF Trial

The FDA's approval was based on results of the BeAT-HF trial, which demonstrated functional gains and improved quality-of-life measures for patients using the Barostim system. The trial provided compelling evidence of the system's effectiveness in treating HF, leading to the FDA's decision to approve expanded labeling.

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Market Impact of the Expanded Label

With the expanded label, the annual market opportunity for Barostim has been revised to $2.2 billion, representing a 60% increase. This is based on new long-term safety and efficacy data, which has increased the number of patients considered suitable for the Barostim system by physicians. The expanded label thus not only extends the potential reach of the treatment but also significantly bolsters the U.S. market opportunity for the Barostim neuromodulation system in heart failure treatment.

Conclusion

The FDA's approval of the expanded label for the Barostim system is a critical advancement in heart failure treatment. By including more patients under its purview, the updated labeling ensures that a larger number of HF patients can benefit from this innovative treatment. As more long-term safety and efficacy data becomes available, the potential impact of the Barostim system in the treatment of heart failure is expected to grow even further.

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