February 22, 2023 — CVRx, Inc., a commercial-stage medical device company focused on developing, manufacturing and commercializing Barostim, an innovative extravascular implantable neuromodulation device for patients with cardiovascular diseases, announced today the preliminary topline results of the BeAT-HF, Baroreflex ActivationTherapy for Heart Failure, post-market randomized clinical trial.
The BeAT-HF post-market phase of the multi-center, prospective, randomized, controlled trial assessed 323 patients suffering from heart failure with reduced ejection fraction. The patients were randomized to two groups, treatment with Barostim and guideline directed medical therapy versus guideline directed medical therapy alone. The primary endpoint was a composite of cardiovascular mortality and heart failure morbidity (specifically, worsening heart failure events requiring treatment in the hospital or emergency department). The trial accrued 332 primary events and had a median follow-up of 3.7 years, corresponding to 1,037 patient-years.
While the trial did not reach statistical significance on the primary endpoint, it did contain additional clinically meaningful prespecified analyses that favored Barostim, including:
- all-cause survival, free from LVAD and heart transplant,
- a hierarchical composite (“WinRatio”) analysis of cardiovascular mortality, heart failure events and quality of life, and
- a clinical stability analysis.
In addition, the safety profile of Barostim and the symptomatic improvement at 6 months, that were the basis for the FDA pre-market approval, were shown to be durable through 24 months (where data collection was prespecified).
The Company will host a conference call at 9:00 am Eastern Time onTuesday, February 21, 2023 to discuss the preliminary results of the BeAT-HF post-market phase clinical data and provide education about the prespecified analyses.
The BeAT-HF post-market phase clinical data will be presented at the Transcatheter Heart Failure Therapies Conference (“THT”) on Tuesday, March 21, 2023 at 10:45 am EasternTime in Boston.
“On behalf of the Executive Steering Committee of BeAT-HF, I congratulate CVRx for conducting a rigorous scientific randomized controlled study that spanned 7 years, to assess the benefits and risks of Barostim inpatients with chronic heart failure with reduced ejection fraction,” said Michael R. Zile, M.D., Distinguished University Professor, Medical University of South Carolina. “The new results from the post-market phase of BeAT-HF confirm Barostim’s long-term symptomatic benefits and safety, and its use as an effective treatment for heart failure.”
“We are grateful to all the patients who enrolled in BeAT-HF, to the investigators in the 108 clinical sites and to the Executive Steering Committee for their dedicated effort over the years,” said Nadim Yared, President and CEO of CVRx. “This new evidence is welcome news for the many patients with heart failure, who remain symptomatic despite optimal medical therapy. We plan to submit the totality of evidence of BeAT-HF to FDA seeking anexpansion of Barostim labeling.”
For more information: www.cvrx.com