CVRx announced today that it observed positive six-month results from its BeAT-HF trial for the Barostim Neo device for improving symptoms of heart failure.
Barostim Neo uses patented technology to send electrical pulses to baroreceptors in the wall of the carotid artery in an effort to restore balance to the automatic nervous system and improve the symptoms of heart failure.
The results, published in the Journal of the American College of Cardiology, were used to obtain FDA premarket approval for the Bariostim Neo.
BeAT-HF was a multi-center, prospective, controlled trial with patients randomized one-to-one to receive Barostim Neo, plus optimal medical management, or optimal medical management alone in the control. The trial included 264 patients with the following key qualifications:
- NYHA Class III or Class II (with recent history of Class III)
- Left ventricular ejection fraction ≤ 35%
- On current HF guideline-directed medical therapy
- NT-proBNP < 1600 pg/mL
- Excluded patients indicated for CRT according to AHA/ACC/ESC guidelines
After six months, CVRx found that Barostim Neo is safe to use for patients with heart failure, recording a MANCE (major adverse neurological and cardiovascular-related device or procedure event-free)-free rate of 97%.
Patients also demonstrated significant improvements in certain symptomatic endpoints, including quality of life, exercise capacity and functional status (65% functional with the Barostim Neo vs. 31% in the control).
“Publication of the BeAT-HF trial results in the esteemed, peer-reviewed JACC journal provides further validation that we finally have an effective neuromodulation therapy for advanced HF patients, who did not have access to device-based therapy.” Medical University of South Carolina professor of medicine & BeAT-HF executive steering committee chairperson Dr. Michael Zile said in a news release. “The Barostim Neo improves patient-centered symptomatic endpoints of quality of life score, exercise capacity and functional status.
“These results are supported by objective evidence of a significant reduction in NT-proBNP, which in recent studies was associated with a lower rate of cardiovascular death or heart failure hospitalization.”
CVRx CEO Nadim Yared will be featured on this week’s episode of the DeviceTalks Weekly podcast.