News release: BAROSTIM™ NEO Associated with Very High Responder Rates in Women
MINNEAPOLIS, June 23, 2020 /PRNewswire/ — CVRx, Inc., a private medical device company, announced new BeAT-HF trial results from late-breaking clinical science presented virtually at the European Society of Cardiology Heart Failure 2020 Scientific Sessions. The BAROSTIM NEO provided significant improvements in quality of life and exercise capacity, with high responder rates in women.1
Heart failure affects millions of women worldwide. It is the leading cause for hospitalizations and a major cause of death in women over 65 years of age.2 There is a need for advances in heart failure therapies for women to improve their symptoms and quality of life. Women have been historically underrepresented in clinical trials.3 Some treatments for heart failure are not as effective in women as in men. Furthermore, despite being more symptomatic than men, women with HFrEF are often undertreated.4 JoAnn Lindenfeld MD, BeAT-HF clinical trial steering committee member, has been active in increasing participation of women in clinical trials for more than 20 years, since one of the early trials with beta blockers for heart failure.5,6,7
“These new results from the BeAT-HF trial demonstrate that the BAROSTIM NEO works quite effectively in women,” said JoAnn Lindenfeld MD, Professor of Medicine, Director of Heart Failure and Transplant at the Vanderbilt University Medical Center. “In symptomatic heart failure patients with a reduced ejection, the BAROSTIM NEO improved multiple measures of functional status and was associated with very high responder rates. The treatment was as effective in women as it was in men. The results support BAROSTIM NEO’s use in all indicated patients.”
BeAT-HF was a multi-center, prospective, randomized, controlled trial. Patients were randomized one-to-one to receive BAROSTIM NEO plus optimal medical management or optimal medical management alone (Control)8.
- NYHA Class III or Class II (with recent history of Class III)
- Left ventricular ejection fraction ≤ 35%
- On current heart failure guideline-directed medical therapy
- NT-proBNP < 1600 pg/mL
- Excluded patients indicated for CRT according to AHA/ACC/ESC guidelines
About Heart Failure and BAROSTIM NEO
Heart failure with reduced ejection fraction (HFrEF) affects over 3 million people in the United States and 13 million people worldwide.9,10,11 It is associated with poor life expectancy, frequent heart failure hospitalizations, poor quality of life and substantial limitation in exercise capacity. The BAROSTIM NEO is designed to treat these patients by electrically activating the baroreflex, the body’s natural mechanism to regulate cardiovascular function. The BAROSTIM NEO device is the world’s first neuromodulation device approved for heart failure patients.
About CVRx, Inc.
CVRx, Inc. is a privately held company founded in 2001 and headquartered in Minneapolis, Minnesota. The company has developed the BAROSTIM NEO. It is a minimally invasive implantable system approved for use in heart failure in over 30 countries, including the United States and approved for use in resistant hypertension in the European Economic Area, Colombia and New Zealand.
- ESC-HF – https://www.escardio.org/Sub-specialty-communities/Heart-Failure-Association-of-the-ESC-(HFA)/Research-and-Publications/HFA-Discoveries#live
- Walsh MN, Jessup M, Lindenfeld J. Women With Heart Failure: Unheard, Untreated, and Unstudied. J Am Coll Cardiol. 2019; 73(1):41-43.
- Dewan P, Rørth R, Jhund PS, et al. Differential impact of heart failure with reduced ejection fraction on men and women. J Am Coll Cardiol. 2019; 73:29–40.
- Lindenfeld J, Krause-Steinrauf H, Salerno J. Where are all the women with heart failure? J Am Coll Cardiol. 1997; 30(6):1417-1419.
- Merrill M, Sweitzer NK, Lindenfeld J, Kao DP. Sex Differences in Outcomes and Responses to Spironolactone in Heart Failure With Preserved Ejection Fraction: A Secondary Analysis of TOPCAT Trial. JACC Heart Fail. 2019; 7(3):228-238.
- Vaduganathan M, Tahhan AS, Alrohaibani A, et al. Do Women and Men Respond Similarly to Therapies in Contemporary Heart Failure Clinical Trials?. JACC Heart Fail. 2019 ;7(3):267-271.
- BeAT-HF results – https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180050b.pdf
- Savarese G, Lund L, Global Public Health Burden of Heart Failure Card Fail Rev, 2017 Apr; 3(1): 7-11.
CVRx, BAROSTIM NEO and BAROSTIM THERAPY are trademarks of CVRx, Inc. registered in the United States Trademark Office. © CVRx, Inc. 2020. All rights reserved.