BAROSTIM NEO System - P180050 wins USFDA approval

Barostim NEO system gets the USFDA approval to treat advanced heart failure. An implantable pulse generator (IPG), a carotid sinus lead kit and a programmer are included in the BAROSTIM NEO System. Electrical signals are delivered by IPG to the pressure sensors of body (baroreceptors) in patients with advanced heart failure.

Implantation of the BAROSTIM NEO IPG under the skin of patient is done by doctor, below the left or right collarbone and carotid sinus lead is placed on the patient's left or right carotid sinus. Electrical signals are delivered by IPG to the baroreceptors on one of the carotid arteries.

The BAROSTIM NEO® System can be used in patients, 21 years or older who have advanced heart failure symptoms and are not responding to medical therapy such as cardiac resynchronization therapy.

This system should not be used in patients, who have anatomy which can impair the device implantation; disorders of nervous system such as arrhythmia or atherosclerosis and known allergy to metals like silicon or titanium.