MONDAY, Aug. 19, 2019 (HealthDay News) -- 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.