Skip to Content

Barostim Neo System Implant Approved to Improve Symptoms in Advanced Heart Failure

MONDAY, Aug. 19, 2019 -- The Barostim Neo System was granted U.S. Food and Drug Administration approval to treat symptoms of patients with advanced heart failure who are not candidates for treatment with other devices such as cardiac resynchronization therapy, the agency announced on Friday.

The device includes a pulse generator implanted below a patient's clavicle and connected to a lead attached to the carotid artery. A physician tests and programs the device after implantation. The Barostim Neo System delivers electrical impulses to baroreceptors to ultimately inhibit production of stress-related hormones and reduce heart failure symptoms. Indications for treatment with the device include regular heart rhythm, not being a candidate for cardiac resynchronization therapy, and left ventricular ejection fraction of ≤35 percent. Contraindications include anatomy that could impair device implantation, certain nervous system disorders, uncontrolled and symptomatic slow heart rate, atherosclerosis, and a known allergy to silicone or titanium.

Approval of the device was based on data from a prospective, multicenter, two-arm, randomized clinical trial of 408 patients with advanced heart failure. All patients received guideline-directed medical therapy and medication, and 125 patients also received the Barostim Neo System implant. Those who received the device improved in six-minute walking tests and reported improvements in quality of life.

Potential complications from the device or implantation include infection, reoperation, low blood pressure, nerve damage, surgical or anesthetic complications, allergic reaction, arterial damage, heart failure exacerbation, stroke, and death. The FDA is requiring the manufacturer to conduct a postapproval study on the device's ability to prolong life and reduce the need for hospitalization.

Approval was granted to CVRx.

More Information

© 2020 HealthDay. All rights reserved.

Posted: August 2019

Read this next

Many Older Americans With Heart Failure Take 10 or More Meds

TUESDAY, Oct. 13, 2020 -- When older people hospitalized for heart failure are sent home, they are often given a whopping 10 medications to take for a variety of conditions. But...

AHA News: A Clean Bill of Health at Birth, His Heart Failed at 2 Months

TUESDAY, Sept. 8, 2020 (American Heart Association News) -- Like many first-time moms, Stephanie Tawata was anxiously navigating the ups and downs of a newborn. She was grateful...

AHA News: Unpredictability of Advanced Heart Failure Complicates End-of-Life Care, Doctors Say

MONDAY, Aug. 31, 2020 (American Heart Association News) -- Some people with advanced heart failure live for a long time, while others don't. That uncertain timeline poses...