CVRx, Inc. (NASDAQ:CVRX) (“CVRx”), a commercial-stage medical device company, announced today that the U.S. Food and Drug Administration (FDA) has approved 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,” 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.”
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 6, 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 at www.cvrx.com/ifu, and the Clinical Summary section of that IFU can be found at pages 24 to 39.
Annual Market Opportunity Update
Our 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 our commercial experience, and to account for the new reimbursement assignment for Barostim. We believe the U.S. annual market opportunity is now $2.2 billion, or 76,000 new patients, as compared to our earlier estimate of $1.4 billion, or 55,000 new patients, representing increases of approximately 60% and 38%, respectively.
