The Food and Drug Administration (FDA) has approved the Barostim Neo System (CVRx, Inc.) for the improvement of symptoms of heart failure – quality of life, 6-minute hall walk and functional status – for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤35%, an N-terminal pro b-type natriuretic peptide (NT-proBNP) <1600pg/mL and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.
The device includes an implantable pulse generator (IPG), a carotid sinus lead kit and a programmer. The IPG is inserted below the collar bone and connected to a lead that attaches to the carotid artery in the neck. After the device is implanted, the IPG delivers electrical impulses to the baroreceptors on one of the carotid arteries. Physicians will be able to customize the IPG to meet the patient’s therapeutic needs.
The approval was based on data from the pivotal, multicenter, two-arm, phase 3 BeAT-HF (Baroreflex Activation Therapy for Heart Failure) trial that evaluated the safety and efficacy of Barostim Neo in improving symptoms in 408 patients with advanced heart failure (HF). All patients received optimal medical management, including medication, and 125 patients were randomized to receive the Barostim Neo system implant.
Results demonstrated that patients in the Barostim Neo treatment arm improved their quality of life score by 14 points using the Minnesota Living with Heart Failure Questionnaire; improved their exercise capacity by 60 meters as measured by the standardized 6-minute hall walk test; and improved their functional status as assessed by their NYHA classification. Significant reductions of NT-proBNP also supported the use of the device in HF patients.
Regarding safety, implantation or use of the device may be associated with the following complications: infection, need for reoperation, hypotension, fainting, and/or falls, nerve damage, surgical or anesthetic complications, allergic reaction, arterial damage, exacerbation of heart failure, stroke and death.
“With the FDA’s approval of the Barostim Neo, we finally have an effective neuromodulation therapy for advanced heart failure patients who are not indicated for Cardiac Resynchronization Therapy (CRT),” said Michael Zile, MD, Professor of Medicine at the Medical University of South Carolina and chairperson of the BeAT-HF Executive Steering Committee. “The Barostim Neo improves the quality of life and the exercise capacity of heart failure patients who previously did not have access to a device-based therapy.”
For more information visit CVRx.com.