FDA approves Barostim Neo to treat HF symptoms
The FDA on August 16 granted breakthrough designation to CVRx Inc.’s Barostim Neo System, a device meant to improve heart failure symptoms in patients unsuited for other therapies like CRT.
The Barostim Neo is indicated for use in patients who have a regular heart rhythm, aren’t candidates for cardiac resynchronization therapy and have a left ventricular ejection fraction of 35% or less, according to a release from the FDA. The system includes a pulse generator that is implanted below a patient’s collarbone and is connected to a lead that’s attached to the patient’s carotid artery.
After implantation under the collarbone, a physician tests and programs the Barostim Neo to deliver baroreceptors—electrical impulses that can sense how blood is flowing through the carotid artery and relaying information to the brain. In turn, the brain sends signals to the patient’s heart and blood vessels that relax the vessels and inhibit the production of stress-related hormones, thereby reducing HF symptoms.
“Patients with advanced heart failure have limitations of physical activity, experiencing fatigue, palpitation or shortness of breath with activity and may not benefit from standard treatments, including currently marketed drugs and devices,” Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, said in the agency’s statement. “This approval provides patients with a new treatment option for the symptoms associated with advanced heart failure.”
The Barostim Neo is contraindicated in patients with certain nervous system disorders, uncontrolled and symptomatic heart rate, atherosclerosis or ulcerative plaques near the implant location. Potential complications include infection, low blood pressure, nerve damage, arterial damage, stroke and death.
The FDA approved the device based on the results of a prospective, multi-center, randomized clinical trial that enrolled 408 patients with advanced HF and found those implanted with the Barostim Neo System showed improvement in their HF symptoms, quality of life and physical abilities.
After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.