This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: BAROSTIM NEO® System
PMA Applicant: CVRx, Inc.
Address: 9201 West Broadway Avenue, Suite 650, Minneapolis, Minnesota 55445
Approval Date: August 16, 2019
Approval Letter: Approval Order
What is it? The BAROSTIM NEO System includes an implantable pulse generator (IPG), a carotid sinus lead kit and a programmer. The IPG delivers electrical signals to the body's pressure sensors (baroreceptors) in patients with advanced heart failure.
The programmer allows medical personnel to control the settings of the device.
How does it work? A doctor implants the BAROSTIM NEO IPG under the patient's skin, below the left or right collarbone and places a carotid sinus lead on the patient's left or right carotid sinus. The IPG is then connected to the carotid sinus lead. The doctor programs the IPG based on the patient's individual requirements. The IPG delivers electrical impulses to the baroreceptors on one of the carotid arteries.
When is it used? The BAROSTIM NEO® System is intended to be used in patients 21 years or older who have advanced symptoms of heart failure and are not responding to medical therapy or who are not suited for treatment with other heart failure devices such as cardiac resynchronization therapy.
What will it accomplish? The BAROSTIM NEO® System was evaluated in a clinical study that compared patients who received the device and standard medical therapy with patients who received only standard medical therapy. The study results demonstrated that the device may improve an individual's ability to perform normal daily activities, distance walked, quality of life, and lower levels of a biomarker that measures heart failure.
When should it not be used? The BAROSTIM NEO® System should not be used in patients who have:
- Anatomy that would impair implantation of the device,
- Certain nervous system disorders, uncontrolled or irregular heart rate, atherosclerosis or blood vessel irregularities near the implant location,
- A known allergy to silicone or titanium.
Additional information (including warnings, precautions, and adverse events):