FDA Approves Expanded Labeling of Barostim

CVRx Inc. has been granted U.S. Food and Drug Administration (FDA) approval of 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,” CVRx President/CEO Nadim Yared said. “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 Update
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/ml. Barostim delivers Baroreflex Activation Therapy to improve patients’ heart failure functional status, six-minute hall walk, and quality of life."
 
The revised Clinical Summary section of the IFU now includes the primary endpoint results; the six, 12 and 24 month symptomatic data; the win ratio; and the all-cause mortality data. 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 revised IFU document can be found here, and the Clinical Summary section of that IFU encompasses pages 24-39.
 
CVRx’s estimate of the U.S. annual market opportunity for Barostim has been revised to increase the number of patients considered by physicians based on this new long-term safety and efficacy data as well as commercial experience, and to account for the new reimbursement assignment for Barostim. Consequently, the company claims the U.S. annual market opportunity is now $2.2 billion, or 76,000 new patients, as compared to an earlier estimate of $1.4 billion, or 55,000 new patients, representing increases of approximately 60% and 38%, respectively.
 
CVRx develops and commercializes the Barostim System, the first medical technology approved by the FDA that uses neuromodulation to improve heart failure symptoms. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the carotid artery wall. Baroreceptors 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 the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the United States. It has also received the CE Mark for heart failure and resistant hypertension in the European Economic Area.