The Barostim Neo (CVRx) implantable pulse-generator system has gained US Food and Drug Administration (FDA) approval for reduced-ejection-fraction heart failure (HF) deemed unsuitable for other device therapies, the agency announced today.
Neuromodulation therapy using the Barostim, which resembles a standard pacemaker with a lead system but stimulates carotid baroreceptors, led to functional gains and improved quality-of-life measures in the recent randomized BeAT-HF trial.
The pulse generator is typically implanted subcutaneously below the left or right collarbone with the lead positioned at the adjacent carotid sinus.
The approved FDA indication includes adults with medically refractory advanced HF and an ejection fraction ≤ 35%who aren't good candidates for other device therapies, especially cardiac resynchronization therapy.
Such patients, who have few other remaining treatment options short of ventricular assist devices or transplantation, make up perhaps half of patients with heart failure.
The treatment modality, called baroreflex activation therapy, is thought to counter neurohormonal effects of HF and ventricular remodeling by inhibiting sympathetic activity and enhancing parasympathetic activity, as previously described by theheart.org | Medscape Cardiology.
"As part of the approval of this device, 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," the agency said.
Cite this: FDA Approves New Form of Device Therapy for Heart Failure, the Barostim Neo - Medscape - Aug 16, 2019.