Public health agency the US Food and Drug Administration on Friday cleared the Barostim Neo System for the improvement of symptoms in patients with advanced heart failure under a breakthrough device designation and the Premarket Approval (PMA) pathway.

According to the agency, Barostim Neo System is indicated for patients who have a regular heart rhythm, but not candidates for cardiac resynchronization therapy and have a left ventricular ejection fraction of less than or equal to 35%, which is considered below the normal ejection fraction of 55 to 75%. The leading causes of heart failure are high blood pressure and diabetes.

The agency reportedly granted approval of the Barostim Neo System to CVRx Inc.

In addition, the Barostim Neo System includes a pulse generator that is implanted below the collar bone and connected to the carotid artery in the neck. The device delivers electrical impulses to cells in the neck and relays information to the brain. The brain sends signals to the heart and blood vessels that inhibit the production of stress-related hormones to reduce heart failure symptoms, said the agency.

Based on the company's prospective, multi-centre, two-arm, randomized clinical trial in 408 patients with advanced heart failure, the patients with the implant showed improvements in walking tests as well as improvements in how symptoms impacted their quality of life.

In conjunction, the FDA is requiring the manufacturer to conduct a post-approval study investigating the potential of the therapy to prolong life and reduce the need for patient hospitalization.