The United States Food and Drug Administration (FDA) has granted Premarket Approval to CVRx Inc, a private medical device company, to market its BAROSTIM NEO device for heart failure in the United States, it was reported on Friday.

The FDA's Center for Devices and Radiological Health approved the firm's submission after a thorough review of the clinical trial data from the Baroreflex Activation Therapy for Heart Failure (BeAT-HF) Pivotal Trial. This was a randomised clinical trial that confirmed the safety of BAROSTIM NEO and its effectiveness in improving symptoms in patients suffering from chronic heart failure.

BAROSTIM NEO uses CVRx-patented technology designed to trigger the body's main cardiovascular reflex to treat patients suffering from chronic heart failure. The therapy is designed to address a significant unmet medical need in heart failure with reduced ejection fraction. It was one of the first therapies to receive the FDA's 'Breakthrough Device' designation.