CVRx receives PMA for heart failure deviceOctober 8, 2019
CVRx has received premarket approval (PMA) from the USFDA to market its Barostim Neo device for heart failure in the US.
The FDA’s Center for Devices and Radiological Health (CDRH) approved the company’s submission after a review of the clinical trial data from the Baroreflex Activation Therapy for Heart Failure Pivotal Trial (BeAT-HF).
The BeAT-HF phase III randomized clinical trial confirmed the safety of Barostim Neo and its effectiveness in improving symptoms in patients suffering from chronic heart failure, the company said.
The trial analysis included results from 264 patients randomized to two arms: 130 subjects randomized to receive a Barostim Neo were compared to 134 subjects randomized to stay on guideline-directed medical therapy.
NYHA class III or class II (with the 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.
Designed to address a significant unmet medical need in heart failure with reduced ejection fraction, the Barostim Neo was one of the first therapies to receive the FDA’s Breakthrough Device designation.
Barostim Neo uses CVRx-patented technology to trigger the body’s main cardiovascular reflex to treat patients suffering from chronic heart failure.